Catalog Number 0279401200 |
Device Problem
Continuous Firing (1123)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device continuously activated.
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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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Manufacturer Narrative
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Alleged failure: the electrode wouldn't stop the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the polyimide's pin became exposed and indirect contact (sparks) with the hood during use, creating a short circuit (hole in the hood) between the active pin and the hood disabling the unit to continue operation.Lack of glue around the polyimide, the glue could have been scratched during the placement of the hood and damaged during pin bending.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Event Description
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It was reported that the device continuously activated.
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Search Alerts/Recalls
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