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 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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.Gtin: (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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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: insulation crack the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be normal wear, or improper sterilization methods.(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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Search Alerts/Recalls
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