Catalog Number 3910-900-093 |
Device Problems
Break (1069); Mechanical Problem (1384); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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Pre investigation results, the needle was bent resulting in that the needle became bent while the device was in use.
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Manufacturer Narrative
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Alleged failure: the instruments had a problem with the needle when passing the suture thread.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) attempt to pass through thick tissue or bone, 3) excessive tissue loaded into jaws, 4) attempt to load or pass incompatible suture, 5) technique error.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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Pre investigation results, the needle was bent resulting in that the needle became bent while the device was in use.
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Search Alerts/Recalls
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