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Model Number A0393 |
Device Problems
Break (1069); Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not expected to be returned for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.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, that the olympus high frequency cable, monopolar, cautery appeared to be not working once plugged, there was a loud snap and spark, and the cord seem to break off of the cautery unit.No harm to patient or other has been reported to olympus.
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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 correction to d9.Please see updates to d9, h6, and h10.The device history record was unable to be reviewed for this device since the lot number was not provided.Olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the age-related wear in connection with repeated extreme bending or tensile loads led to the breakage of wire(s) in the cable.Additionally, it¿s probable a voltage spike occurred at the damaged area when the generator activated, resulting in a spark and complete disconnection of the plug.It¿s likely the reported event is due to wear and tear in connection with improper handling, however, a final root cause was unable to be identified as he device was not returned for evaluation.
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Search Alerts/Recalls
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