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Model Number WA22302D |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1/establishment name: (b)(6).The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the loop broke on the olympus high frequency resection electrode.The issue was found during therapeutic transurethral resection of the prostate (turp).The procedure was completed with similar device.There was the patient was under general anesthesia.There was no report of delay, patient injury, or medical intervention associated with this event.
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Manufacturer Narrative
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Correction to to d8 ; information inadvertently left out of the initial report.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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