Catalog Number 801400 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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The facility reported the surgical patties are shredding and coming apart.
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Event Description
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N/a.
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Manufacturer Narrative
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Device identifier : (b)(4).The surgical pattie was returned for evaluation: device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the pattie/strip unit was inspected using the unaided eye.No anomalies were observed.The returned unit was found to work as intended and met all acceptance criteria.The complaint could not be verified.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Search Alerts/Recalls
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