Catalog Number 0504990314 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/14/2017 |
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.(b)(4).
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Event Description
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It was reported that the tip of the electrode broke off inside patient.Please note that the event description was reported midway through the case.Additional information obtained confirmed that the tip was successfully removed from the patient before the case was over.
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Manufacturer Narrative
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Alleged failure: broken distal electrode.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or bent/damaged during installation, the product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.(b)(4).
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Event Description
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It was reported that the tip of the electrode broke off inside patient.Please note that the event description was reported midway through the case.Additional information obtained confirmed that the tip was successfully removed from the patient before the case was over.
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Search Alerts/Recalls
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