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
Crack (1135); Peeled/Delaminated (1454)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The following repair and service diagnostic codes were identified based on service request cracked/peeling insulation at tip of shaft, replaced handle.The following was observed: cracked / peeling insulation at tip of shaft.Handle was replaced.This does confirm the alleged failure mode of: insulation damage probable root cause: "poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life".
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Event Description
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It was reported that insulation was cracked / peeling at tip of shaft and broken jaw.
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Manufacturer Narrative
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(b)(4).The following repair and service diagnostic codes were identified based on service request (b)(4): cracked/peeling insulation at tip of shaft, replaced handle.The following was observed: cracked / peeling insulation at tip of shaft.Handle was replaced.This does confirm the alleged failure mode of: insulation damage.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 was cracked / peeling at tip of shaft and broken jaw.
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Search Alerts/Recalls
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