Catalog Number 0250080617 |
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 04/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the insulation had been compromised.
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Event Description
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It was reported that the insulation had been compromised.
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Manufacturer Narrative
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Alleged failure: (b)(6) insulation broken.(b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could (1) improper cleaning or sterilization (2) normal wear.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Search Alerts/Recalls
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