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Catalog Number 22-4038 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/19/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during an arthroscopic procedure, the front end of the "firstpass suture passer" did not open smartly after stitching the tissue.The medical staff needed some time and force to open the mouth to leave the joint.The device was bent during that maneuver.The procedure was successfully completed without significant delay using a back-up device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The image provided by the customer showed the device, but did not reveal any information regarding the functionality.Visual inspection of the device revealed that the needle is protruding from the distal end of the jaw.The device did not perform as intended the needle did not deploy when the lever was pressed.The complaint was verified and the root cause was determined as a manufacturing process error.The failure is being assessed for recommended actions.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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