Model Number KD-V441M |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device has been returned for evaluation and the investigation is in progress.The subject device was returned for evaluation and it was found the wire was broken with energization.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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Event Description
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The customer reported the tip of the kd broke off and was stuck in the papilla.The intended endoscopic retrograde cholangiopancreatography procedure was successfully completed using a tjf endoscope.There was an unspecified procedure delay due to removing the broken segment from the papilla.No patient harm or injury reported.The erbe hf device was normal kd settings.No additional information is available.The device was returned for repair.The olympus service center identified the wire was broken with energization.This is a reportable event.
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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 investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the broken knife wire could not be identified.Olympus will continue to monitor field performance for this device.
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Manufacturer Narrative
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Correction to g3 of the initial medwatch.The aware date should be (b)(6) 2021.Investigation activities have been opened, to manage the actions related to this report and any required mdr reporting.
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Search Alerts/Recalls
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