Catalog Number 22-4035 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a cuff surgery, the surgeon experienced difficulty when using the firstpass suture passer, and ended up breaking it.The broken pieces were completely removed from the patient.The procedure was completed successfully, however, it is unknown how.There was no surgical delay and no further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference case-(b)(4).
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Manufacturer Narrative
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H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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