Catalog Number 0250070443 |
Device Problem
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 08/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available, it will be provided in future reports.(b)(4).
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Event Description
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It was reported that the insulation was compromised.
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Manufacturer Narrative
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(b)(4).The device manufacturer date is not known.Alleged failure: the insulation on the l-tip chipped off.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be user excessive force and/or contact with another instrument while in use during procedure.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
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Event Description
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It was reported that the insulation was compromised.
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Search Alerts/Recalls
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