Model Number WA22355C |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue of loose needle was confirmed.The device evaluation found that the part was loose and bent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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Event Description
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The customer reported to olympus, while preparing for a therapeutic resection case it was found that the needle of the electrode was loose due to an internal mechanism issue, rendering it unable to use.The device was replaced and the intended procedure was completed using a similar device.There were no reports of patient harm.
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Manufacturer Narrative
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This report is being supplemented to inform correction to g2 (report source) of the initial medwatch.The g2 report source of "other" is being updated to singapore which was not included when the initial report was filed.
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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.The e1 "telephone number" and g2 fields were corrected based on information available at the time of the initial submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on inspection findings, it is likely that the loose distal end was caused by wrong handling by the user.Due to the deformation of the electrode at the proximal end, the distal end of the electrode came loose during combination with the working element.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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