Catalog Number 106121 |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
|
|
Event Description
|
Dealer initially reports this instrument has a broken shank and rust found in the boxlock during general surgery in direct contact with patient.No broken parts inside the patient.No harm done.
|
|
Manufacturer Narrative
|
May 12, 2016 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed complaint.Device history evaluation - dhr review.Nonconforming product report / nonconforming material report history: variance authorization / deviation history: there is no applicable variance authorization / deviation history: engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.
|
|
Manufacturer Narrative
|
On 11/8/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - forceps returned in used condition, not showing any unusual markings.The returned forceps showing wear, minimal staining within the hinge and the jaw is broken at hinge.Without knowing how much pressure was used to the jaw, the cause of the complaint is undetermined.Device history evaluation - dhr review.Nonconforming product report / nonconforming material report history: variance authorization / deviation history: there is no applicable variance authorization / deviation history: engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: conclusion: the root cause has not been identified as a workmanship or material deficiency.
|
|
Search Alerts/Recalls
|