The cystoscopes in question were sent to a laboratory for microbiological testing.Following the microbiological testing, the devices were sent to olympus for evaluation.The evaluation results are as follows:
cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found reddish-orange residue inside the device.The evaluation also found that the device failed leak testing at the control body.Cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found white residue in the instrument channel port and on the distal end of the device.The evaluation also found deep cuts in the insertion tube.Cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found white residue in the instrument channel port and on the distal end of the device.The evaluation also found a leak at the air valve.Cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found white residue in the instrument channel port and on the distal end of the device.The evaluation also found 8 broken image fibers and a leak at the eto valve.Based on the device evaluation results, the most likely cause of the reported events is due to improper maintenance of the device.
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Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015.Based upon this review, we are submitting this mdr to separately account for each of the ten patients involved in this event.Olympus was informed that ten patients tested positive for urinary escherichia coli (e.Coli) infections after undergoing diagnostic cystoscopy procedures, with four different cystoscopes.It was unknown which of the four devices (sn.(b)(4)) are alleged to be the source of the infections.All patients have reportedly recovered.Please cross reference mfr.Report numbers: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00186, 8010047-2010-00190, 2951238-2016-00156, 2951238-2016-00157, 2951238-2016-00158, 2951238-2016-00159, and 2951238-2016-00160 to account for the ten patients as referenced in the original report.The following four reports will be supplemented to cross reference the ten associated infection complaints: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00186 and 8010047-2010-00190.
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