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Model Number PK-CF0533 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly following investigations.
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Event Description
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When device pk-cf0533 forceps were removed from packaging debris present found.The debris could be seen through the plastic packaging.The issue found prior to a tubal ligation procedure.The device was replaced and the intended procedure was completed.No harm, impact to the patient was reported.No user injury reported.
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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 investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Return device was evaluated.Visual inspection as received condition found no abnormality on the appearance.The tray was completely sealed and has no physical damage.Without opening the top lid, and inspected the device as is under a magnify lamp found no debris anywhere inside the packaging.The top lid was then removed to inspect the content inside but still no debris was found.The tray has good adhesive around the edges, and the device is clean.Therefore, the reported complaint was not confirmed.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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