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Catalog Number 101010 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/25/2022 |
Event Type
malfunction
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Event Description
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A rupture in the sterile barrier was noticed prior to surgery, compromising the device sterility.Device was not used, surgery was rescheduled.
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Manufacturer Narrative
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Product and packaging investigated.Based on the information available, the exact cause of the rupture cannot be established.Corrective and/or preventative action has not been determined.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
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Search Alerts/Recalls
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