Model Number GF-UCT180 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The medwatch report provided an incorrect serial number for the model gf-uct180 scope; therefore, it is unknown if the device was returned olympus for evaluation and/ or service.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event.If additional information becomes available at a later time, this report will be updated accordingly.
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Event Description
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Olympus received a medwatch report which states that during routine culturing the scope tested positive for positive for a carbapenem-resistant enterobacteriaceae (cre).According to the report, the scope last cultured negative on (b)(6) 2018.The scope has been used 11 times between (b)(6) and (b)(6).The scope was reportedly returned to the manufacturer for repair on april 19, 2018 and was not utilized again up to the time of the routine scope culturing.There were no associated patient infections reported.
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Manufacturer Narrative
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This supplemental report is being submitted to report additional information from the ess.As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.The customer declined the ess visit.
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Manufacturer Narrative
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This supplemental report is being submitted to make a correction on the procode from itx to odg.
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Search Alerts/Recalls
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