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Catalog Number 22-4039 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/19/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a shoulder surgery, the firstpass suture passer was faulty, it had both jaws closed and would not open.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or other 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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H10: h3,h6: the device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2047482 found no non-conformances or anomalies during manufacturing process related to the reported event.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
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Search Alerts/Recalls
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