Model Number ED-580XT |
Device Problems
Improper or Incorrect Procedure or Method (2017); Electrical Shorting (2926)
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Patient Problem
Bowel Burn (1756)
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Event Date 03/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Fujifilm and fda previously collaborated to investigate the root cause of the mucosal burns.It was determined that the burns were considered minor injuries and recurrence of the issue would not likely lead to a serious injury.However, fujifilm became aware of three total mucosal burn incidents involving the same doctor.As such, fujifilm is submitting this report in an abundance of caution.The other incidents will be reported separately.A safety notice was distributed to all active customers on march 31, 2022 regarding the mucosal burn issue.They were also instructed to ensure that the full proximal end of the wire of the high-frequency device is visualized on the endoscope monitor and to review the user manuals for both the endoscope and the high-frequency device.
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Event Description
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On (b)(6) 2022, fujifilm corporation was informed of an incident that occurred during an ercp procedure involving ed-580xt.It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) sphincterotomy, the subject scope cut right and burned the duodenum.The performing physician stated that leakage from the tip of the scope during the procedure caused cautery of the duodenal wall.No additional intervention was required and the procedure was completed successfully.Two separate incidents were reported involving separate ed-580xt scopes.This report addresses the second scope with serial # (b)(4).There was no death associated with the event, and the burn was determined to be minor.As such, this report is being submitted in an abundance of caution.
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Manufacturer Narrative
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On may 29, 2022, fujifilm corporation conducted the root cause investigation and scope inspection.The ed-580xt scope was inspected and found to be performing as intended.There were no abnormalities identified within the subject scope that could lead to burns or harm to a patient.In addition, the physician at the affected site stated that no further follow-up from fujifilm was required.Therefore, the original investigation conclusion is confirmed.
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Manufacturer Narrative
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This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.
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Search Alerts/Recalls
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