Model Number CYF-5 |
Device Problem
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 Type
malfunction
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Manufacturer Narrative
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The referenced scope was returned to the service center for evaluation.The evaluation confirmed the reported event as the biopsy mount/biopsy port was missing.Additionally, the scope has a 3rd party bending section cover, a loose eto (ethylene oxide) valve and the image back-focus alignment is off and scratches on the distal end cover body.The device was repaired to standard specifications and returned to the customer.A review of the scope's repair history showed the scope was last serviced via repair on (b)(6) 2020 due to a ruptured bending section cover.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The sterile processing supervisor at the user facility reported that during reprocessing the biopsy port was reportedly missing.The event prior to reprocessing was a diagnostic procedure and the procedure was completed using the same device.The device did not fail during procedure as the failure was first observed during reprocessing.There was no report of patient injury, infection or harm.
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Manufacturer Narrative
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This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h4, h6 and h10 the legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.This root cause of the reported malfunction is attributed to damage to the forceps closure gold due to handling.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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