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Model Number WA00014A |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the high frequency-cable, bipolar did not turn on during a procedure.The procedure was completed replacing a code with the same product.After replacing the a code with the same product, the problem was resolved, so the combined product set, esg-400, was not issued.There were no reports of patient harm.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the cable was broken around the control part side cap 1 (straight type connector).Traces of melting discoloration that appeared to be scorching were seen at the fractured part.Regarding the cause of the cable breakage, it is believed that the internal core wire gradually broke due to repeated bending, pulling, and other loads, and eventually the cable broke because it was energized with point contact.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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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.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 investigation, the root cause of the event was unable to be identified.The event likely occurred due to age-related wear and tear in combination with improper handling by the user like application of mechanical force, stress, bending and pulling.The event can be detected/prevented by following the instructions for use which state: "the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Furthermore, the cable must be checked for a damage prior to each use and after reprocessing.By gently pulling on the plug (with a maximum of 20 n) the user can determine if there is pre-existing damage to the stranded copper wire of the cable.If the cable does not buckle but remains firm, the cable is most likely fine in this place.Finally, in order not to increase the service life of the cable, the cable should not be wound up with a loop diameter of less than 10 cm, and the user should pull on the connector and not on the cable when unplugging the cable.".Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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