Catalog Number 0250080618 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/17/2016 |
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.
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Manufacturer Narrative
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Visual inspection: a crack on the insulation was noticed at the distal.Functional inspection: the instrument failed the insul scan test.The probable root cause/s could be normal wear, user misuse, and improper sterilization methods.The failure(s) identified in the investigation is consistent with the complaint record.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.(b)(4).
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Event Description
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It was reported the insulation is cracked.
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Search Alerts/Recalls
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