Catalog Number 0250080617 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/26/2018 |
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 insulation had been compromised.
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Manufacturer Narrative
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The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: eib pcs jen, failed insulation.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be improper cleaning/sterilization or normal wear.Although the product passed the insulscan, the failure identified in the investigation is consistent with the complaint record because there were dents and scratches on the insulation.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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