Catalog Number 0250040112 |
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 11/30/2017 |
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.(b)(4).
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Event Description
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It was reported that the device failed the insulation test.
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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: these failed the insulation test way too early.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.Mfg date: manufacture date is not known.(b)(4).
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Event Description
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It was reported that the device failed the insulation test.
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Search Alerts/Recalls
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