Model Number TJF-Q180V |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation but returned to ofr on (b)(6) 2017.The subject device is under evaluation by (b)(4).Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present, if significant additional information is received, this report will be supplemented.
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Event Description
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Olympus (b)(4) was informed that five patients tested (b)(6) for (b)(6) after having undergone endoscopic retrograde cholangiography (ercp) using the subject device between (b)(6) 2016 at the facility.The facility reported that four patients are doing well except for one patient ((b)(6) years old ) who deceased of the patient¿s pathology.There was no other detailed information on the cause of the death of the one patient at present.The subject device was reprocessed using non-olympus automated endoscope reprocessor (solscope series 4) and the forceps elevator was replaced according to an olympus field corrective action on (b)(6) 2016.The facility conducted additional microbiological test for the subject device on (b)(6) 2017 and confirmed the result cleared the criteria of (b)(6) guideline of (b)(6) 2007 (elements of quality assurance in health related to the microbiological of endoscopes control and traceability in endoscopy).The routine microbiological test of the subject device, which was conducted by the facility before the procedure for the patients, reportedly cleared the guideline this is four of five reports.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the device evaluation result.Olympus followed up the facility to obtain additional information and was informed that the facility confirmed that the death of the patient was not attributed by the infection but due to her pre-existing pathology.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was send to a third party laboratory for additional microbiological testing.In the additional test, the testing result obtained for the subject device was defined as target level according to the statement by (b)(6) dgos/pf2/dgs/vss1/2016220 from (b)(6) 2016).This is four of five reports.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Olympus followed up the facility to obtain additional information on the reprocessing practice at the user facility and was informed that the facility had cleaned the distal end of the subject device with olympus brush (maj-1888) and had cleaned the instrument channel with non-olympus brush (kit 1-clean 1.8mm, prince medical).Except for the use of non-olympus brush, there was no deviation from the instructions of olympus reprocessing manual.Olympus provided reprocessing training for the user facility.This is four of five reports.
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Manufacturer Narrative
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This supplemental report is being submitted to correct rec'd by mfr date in the follow up number 2 supplemental report.The date in the follow up number 2 was not april 25, 2016 but april 25, 2017.
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Search Alerts/Recalls
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