Catalog Number PC9004 |
Device Problem
Temperature Problem (3022)
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Patient Problem
No Information (3190)
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Event Date 11/15/2018 |
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.
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Event Description
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It was reported that there was a thermal event.
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Manufacturer Narrative
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The product was not returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: customer reported flames between the light lead and scope light post attachment during use.Probable root cause: the reported failure mode is consistent with previous failures in which there was residue left over from sterilization between the laparoscope and light guide connection points.This residue burned up and created smoke, leading to darkening and loss of image.Manufacture date is not known.H3 other text : 81.
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Event Description
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It was reported that there was a thermal event.
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Search Alerts/Recalls
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