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Model Number 72202088S |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2021 |
Event Type
Injury
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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, during a hip surgery procedure, the tip/end lens of the scope appeared to be cracked, it could be seen through the eye piece.The procedure was completed with a smith and nephew back up device.No patient injury, delays or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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 visual inspection found distal tip and fiber damage, a cracked negative lens and moisture.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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