Catalog Number 0250080617 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.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 is cracked on the peek monopolare handle.
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Manufacturer Narrative
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Alleged failure: insulation cracked.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes are normal wear, improper sterilization methods, and user misuse.The device manufacture date is not known.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.(b)(4).
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Event Description
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It was reported the insulation is cracked on the peek monopolare handle.
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Search Alerts/Recalls
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