Model Number REXM3-30A |
Device Problem
Sharp Edges (4013)
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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 device was returned to olympus for evaluation and the evaluation found the following that the object window had dents and sharp edges.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The customer reported to olympus the m3-gold autoclavable foroblique telescope 30 deg, distal end burning causing sharp edges.The issue occurred during the reprocessing.The procedure was diagnostic.There are no reports of patient or user harm associated with this event.
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Manufacturer Narrative
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This report is being supplemented to provide corrected information for model number and udi (d4).
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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 customer-provided information.Customer-provided information: additional event information was requested: the customer reported that no further information was available. 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 9 months since the subject device was manufactured.The device instructions for use document was reviewed.Review showed the following relevant instruction: "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects;" "keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active." the device investigation determined the observed damage on the distal end likely occurred due to improper handling.However, the root cause of the complaint could not be conclusively determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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