Catalog Number 0250080230 |
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 08/28/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported the insulation on the shaft tip of the monopolar handle was cracking and peeling.
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Manufacturer Narrative
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The following repair and service diagnostic codes were identified based on service request (b)(4): (b)(4) cracked/peeling insulation at tip of shaft.(b)(4)- 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.Furthermore, reportability decision was check for consistency.¿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 the insulation on the shaft tip of the monopolar handle was cracking and peeling.
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Search Alerts/Recalls
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