Catalog Number 101301 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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Dealer initially reports this instrument tip was broken during pediatric surgery.No broken parts inside the patient.On (b)(6) 2015 dealer reports xray taken confirms no parts left in patient.
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Manufacturer Narrative
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On (b)(6) 2016 integra investigation completed.Failure analysis, device history evaluation 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.Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none engineering change order/manufacturing change order history: none corrective action preventive action history: none health hazard evaluation history: none root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed.
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Manufacturer Narrative
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On 11/8/2016 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis: scissor returned in used condition, not showing any unusual markings.While performing the visual inspection of the scissors, it is noticed that one of the tips is broken.The complaint is confirmed.Device history evaluation: dhr review.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.
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Search Alerts/Recalls
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