Catalog Number 0250181164 |
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 12/09/2017 |
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 was compromised.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: burn on insulation at shaft.Confirmed failure: burn on insulation at shaft.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.The reported failure mode will be monitored for future reoccurrence.Mfg date: manufacture date is not known.Gtin #: (b)(4).
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Event Description
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It was reported that the insulation was compromised.
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Search Alerts/Recalls
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