Model Number H802228240022 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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Same case as: 2134265-2015-09415.It was reported that foreign material was noted.A rotawire was selected to treat an unspecified target lesion.It was noted that there was a white substance on the rotawire that the physician attempted to wipe off.The substance then turned powdery.The physician elected to load a rotaburr on the wire and noticed that more of the substance appeared to be coming off.The physician removed the burr, cleaned the system and attempted to advance the same burr over a new rotawire; however, the same issue occurred.The procedure was completed with the same burr and another of the same rotawire.No patient complications were reported.
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Manufacturer Narrative
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(b)(6).Corrected upn from unk379 to h802228240022.(b)(4).
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Event Description
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It was further reported that when the rota burr was being advanced over the rotawire, "it would almost scrapped a residue." they cut the tip of the wire and removed it.They opened the second wire from the same lot number and box and used it with the same burr and had no problem.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for evaluation.Evaluation of the returned device revealed that it does not have any visual failure related to foreign matter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Event Description
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It was further reported that when the rota burr was being advanced over the rotawire, "it would almost scrapped a residue".They cut the tip of the wire and removed it.They opened the second wire from the same lot number and box and used it with the same burr and had no problem.
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Search Alerts/Recalls
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