Catalog Number 0250181106 |
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 01/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Mfg date: 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.(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 not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: insulation pulling back at distal tip and the post is broken the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.Gtin: (b)(4).Mfg date: manufacture date is not known.
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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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