Catalog Number K12T-08032 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleged the scissors are puncturing through the sterile barrier.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.Corrections were made after the investigation identified the lot received was different than the lot initially reported.
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Search Alerts/Recalls
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