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Catalog Number 72201693 |
Device Problems
Scratched Material (3020); Incomplete or Inadequate Connection (4037)
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Patient Problem
Tissue Damage (2104)
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Event Date 12/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that, during an shoulder arthroscopy, the patient suffered cartilage damages in the humerus as a consequence of an existing gap between the 5.00 mm cannula tip-end (which has a sharp edge) and the arthroscope when connected.As this adverse consequence was noticed after the procedure, the surgery had been finished with the same device, in a timely manner.It is still unknown: (i) the outcome and evolution of the patient; and (ii) if there was any necessary revision surgical intervention to preclude any permanent damage to the cartilage.
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Manufacturer Narrative
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Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.In addition this failure mode that has been evaluated and is being monitored through our post market surveillance team.
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Search Alerts/Recalls
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