Model Number CYF-VHR |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2021 |
Event Type
malfunction
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Event Description
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It is reported in mw5101053, after reprocessing a cysto-nephro videoscope, black specks were noted.There is no reported patient contact/impact related to this occurrence.In mw5101053, this facility reports 6 cases.Report with patient identifier (b)(6) reports case 1 of 6 report with patient identifier (b)(6) reports case 2 of 6 report with patient identifier (b)(6) reports case 3 of 6 report with patient identifier (b)(6) reports case 4 of 6 report with patient identifier (b)(6) reports case 5 of 6 report with patient identifier (b)(6) reports case 6 of 6.
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Manufacturer Narrative
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The device referenced in this report has been returned to olympus for evaluation.Physical evaluation of the complaint device reveals: it was confirmed, the rubber glue was cracked/chipped/peeling.The scope passed the water dunk test.All required repairs were completed and the device was shipped back to the customer meeting safety specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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Manufacturer Narrative
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This report is being updated to report investigation findings.Device history record (dhr)/service history review: a dhr review has been performed for this product and determined that there were no nonconformance's during the manufacturing process of this device.A review of the instructions for use (ifu) shipped with the device provided the customer with the following information regarding the reported event: chapter 5 troubleshooting.5.1 troubleshooting : warning : never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage.If any parts of the endoscope fall off inside the patient body due to equipment damage or failure, stop using the endoscope immediately and retrieve the parts in an appropriate way.Cyf-vh/vhr reprocessing manual : chapter 5 reprocessing the endoscope : 5.5 manually cleaning the endoscope and accessories.Dry external surfaces : 2 inspect the endoscope for residual debris.Should any debris remain, repeat the entire cleaning procedure until all debris is removed.Conclusion: it is presumed that the foreign object, which remained inside the scope, was due to inadequate reprocessing and failure to fully follow the ifu.It was determined the issue was not due to a defect of the device or manufacturing process.
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Manufacturer Narrative
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This report is being updated to report corrected information.Corrected data is reported in d4 (serial number).
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation per capa-200413.Based on the results of the further investigation, although there was a report of foreign matter falling off the forceps channel, the subject device was not used on a patient, nor related to any patient event.This supplemental report includes a correction to d8 from initial medwatch.Information added to d8 that was inadvertently not included on the initial medwatch.Also, h6 codes added.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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