Catalog Number MCO290 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 2523190-2018-00063.
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Event Description
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This report is 1 of 2.The integra sales representative reported on behalf of the customer that on an unknown date, a mco290 bipolar forceps mco290 70mm w/tray was unable to effectively cauterize during an endoscopic sinus surgery.The instrument was used in two office procedures but the surgeon was not able to effectively cauterize with this instrument, the patients had to be taken to the operating room (or).Additional information has been requested but no other clinical information has been provided.
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Manufacturer Narrative
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The device was returned to the manufacturer for physical evaluation.The failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.Product or objective evidence was returned and the evaluation verified the complaint as valid.The active part of the instrument is crooked.This consequence may be due to a shock, a fall or a too violent use.Indeed, this instrument is very sensitive.No manufacturing defects were noted.
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Search Alerts/Recalls
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