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 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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Alleged failure: failed insulation.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.The device manufacture date is not known.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.(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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