Model Number PC9002 |
Device Problems
No Display/Image (1183); Electrical Shorting (2926)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was image loss & thermal event during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.
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Manufacturer Narrative
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Alleged failure: during the thoracoscopic surgery, the control unit skipped and the camera stopped working.See photos attached with the burnt connector.The surgery was delayed for 20 minutes, as the entire column had to be changed probable root cause: the observed cable connector pin damage was a known issue with older generation camera cables.The issue was caused by epoxy escaping the connector and bulging underneath the connector pins after reprocessing, resulting in an upward bend.The issue has been addressed in the current connector redesign by addition of an epoxy dam as well as changing the epoxy to a more durable compound which does not bulge from reprocessing.The device was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future re occurrence.Manufacture date is not known.
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Event Description
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It was reported that there was image loss & thermal event during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.
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Search Alerts/Recalls
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