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Model Number 72203791 |
Device Problem
Misassembled (1398)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that the movable segment of the truepass suture passer tip was not fixed in the working position.It is unknown whether the event happened during surgery and if there was a patient involvement.
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Manufacturer Narrative
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H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the customer provided image revealed the suture capture door is bent along the torsion spring insert.The torsion spring end is extended beyond the outer profile of the upper jaw.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.
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Manufacturer Narrative
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H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image revealed the suture capture door is bent along the torsion spring insert.The torsion spring end is extended beyond the outer profile of the upper jaw.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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