Model Number URF-V |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The event date is (b)(6) 2021, when the adhesive was noted to be peeling on forceps cover.The reporter¿s contact information, occupation and health profession are unknown at this time.Further inspection of the returned device found bite marks on the insertion portion of the scope.The distal end cover was observed to be burnt.Moisture was noted in the scope¿s control unit and the switch box was corroded with short wires.The cause of the physical damage to the scope cannot be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.
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Event Description
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The customer was reported a leak at distal end of the scope.There was no patient involvement report.The device was returned for evaluation and found the scope leaking and protruding metal from the bending section rubber.This report is being submitted to address the protruding metal observed during evaluation.
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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 and to correct information provided on the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon of ¿bending tube metal braid deformed¿ (metal of the bending tube is sticking out) might have occurred due to the same reasons as other damages reported.However, it cannot be specifically determined if the reported event was caused by stress, handling, or other causes.The cause of the reported event cannot be conclusively determined.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 03-nov-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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