GREY:TSTIF - Post by User
Post by
lematou22on Sep 11, 2017 12:26pm
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Post# 26680145
Dirty Scopes in Europe
Dirty Scopes in EuropeFrom the MAUDE system ot the FDA. There's at least one hospital that still cannot manage to clean it`s doddenoscopes even after following Olympus instructions. In this case, it's a french hospital that cannot meet the french standards. A market for the VP4 in Europe?
| | | Model Number TJF-Q180V | | Device Problem Bacterial contamination of device | | Event Date 07/18/2017 | | Event Type Injury | | Manufacturer Narrative | | The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. An inspection was conducted by an olympus staff at the facility. The subject device passed the leakage testing and there was no abnormality noted and no debris observed in its appearance, the distal tip and biopsy channel. Omsc reviewed the manufacture history of the subject device and confirmed the subject device was manufactured after design change of the forceps elevator and there was no irregularity in the history. The subject device was returned to (b)(4) for elevator mechanism breakage on (b)(6) 2016 and sent back to the facility after repair. The exact cause could not be determined at present, olympus is planning to follow up with the facility to assess the detailed reprocessing procedure and evaluate the subject device. If significant additional information is received, this report will be supplemented. | | | | Event Description | | Olympus (b)(4) was informed that five patients tested positive for pseudomonas aeruginosa after having undergone endoscopic retrograde cholangiography (ercp) using the subject device since (b)(6)2017 at the facility. During the initial phase of these events, the test result of the microbiological testing at the facility on (b)(6)2017 cleared the (b)(4) guideline and the facility did not inform (b)(4) of the two patient infections in the beginning of (b)(6). A third patient was reported to be contaminated at the end of (b)(6) and the facility believed the contamination due to the patient itself. The fourth and fifth patients were reported to be contaminated on (b)(6). The facility reported that four patients are doing well except for one patient who was hospitalized with fever. The first microbiological testing for the subject device on (b)(6) was reportedly conducted while the forceps elevator was in a lowered position and the subject device tested positive for unspecified microorganism(1/cfu/190ml) but the test result cleared the french guideline. Additional microbiological testing was conducted in (b)(6) for the subject device while the forceps elevator was in an upper position and the subject device tested positive for pseudomonas aeruginosa (>100cfu/190ml). The subject device was cleaned with olympus brushes (model:bw-412t,maj-1888) and was reprocessed using a non-olympus automated endoscope reprocessor (aer:brandname:wassenburg, model:adapterscope) with peracetic acid. The microbiological testing for the rinsing water of the aer was negative for pseudomonas aeruginosa but some of the test result did not clear the french guideline due to unspecified microbial growth. This is five of five reports | | |
| | | Model Number TJF-Q180V | | Device Problem Bacterial contamination of device | | Event Date 07/18/2017 | | Event Type Injury | | Manufacturer Narrative | | The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. An inspection was conducted by an olympus staff at the facility. The subject device passed the leakage testing and there was no abnormality noted and no debris observed in its appearance, the distal tip and biopsy channel. Omsc reviewed the manufacture history of the subject device and confirmed the subject device was manufactured after design change of the forceps elevator and there was no irregularity in the history. The subject device was returned to (b)(4) for elevator mechanism breakage on (b)(6) 2016 and sent back to the facility after repair. The exact cause could not be determined at present, olympus is planning to follow up with the facility to assess the detailed reprocessing procedure and evaluate the subject device. If significant additional information is received, this report will be supplemented. | | | | Event Description | | Olympus (b)(4) was informed that five patients tested positive for pseudomonas aeruginosa after having undergone endoscopic retrograde cholangiography (ercp) using the subject device since (b)(6)2017 at the facility. During the initial phase of these events, the test result of the microbiological testing at the facility on (b)(6)2017 cleared the (b)(4) guideline and the facility did not inform (b)(4) of the two patient infections in the beginning of (b)(6). A third patient was reported to be contaminated at the end of (b)(6) and the facility believed the contamination due to the patient itself. The fourth and fifth patients were reported to be contaminated on (b)(6). The facility reported that four patients are doing well except for one patient who was hospitalized with fever. The first microbiological testing for the subject device on (b)(6) was reportedly conducted while the forceps elevator was in a lowered position and the subject device tested positive for unspecified microorganism(1/cfu/190ml) but the test result cleared the french guideline. Additional microbiological testing was conducted in (b)(6) for the subject device while the forceps elevator was in an upper position and the subject device tested positive for pseudomonas aeruginosa (>100cfu/190ml). The subject device was cleaned with olympus brushes (model:bw-412t,maj-1888) and was reprocessed using a non-olympus automated endoscope reprocessor (aer:brandname:wassenburg, model:adapterscope) with peracetic acid. The microbiological testing for the rinsing water of the aer was negative for pseudomonas aeruginosa but some of the test result did not clear the french guideline due to unspecified microbial growth. This is five of five reports | | |