STRYKER ENDOSCOPY-SAN JOSE 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
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Catalog Number 0250080617 |
Device Problems
Break (1069); Crack (1135); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The following repair diagnostic codes were identified: cracked/peeling insulation at tip of shaft.This does confirm the alleged failure mode of [insulation scan failed].Probable root cause: poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Contact forces.Product used beyond defined useful life.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that insulation cracked, compromised, broke, or breached (failed insulscan).
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Search Alerts/Recalls
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