Model Number ED-580XT |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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Patient Problem
Bowel Burn (1756)
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Event Date 12/01/2021 |
Event Type
malfunction
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Event Description
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On (b)(6) 2021 fujifilm corporation was informed of an incident that occurred during an ercp procedure.Towards the end of the ercp procedure, a sphincterotomy was performed using the boston scientific truetome 44 sphincterotome and jagwire revolution guidewire, and erbe vio 300 d electrosurgical generator.The sphincterotomy was successful and when the scope was being pulled out to finish the procedure from papilla, they noticed what appeared to be a possible burn on the mucosal wall in the duodenum, opposite to the area where the sphincterotomy was performed.This possible burn was not visible during the sphincterotomy.It was only visible when scope was pulled back.The procedure was completed without any further difficulties.There is no death associated with event.
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Manufacturer Narrative
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Fujifilm is performing additional investigation to determine the root cause.A supplemental report will be submitted pending results of the investigation.Additionally, this is the sixth incident involving the ed-580xt scope and a non-fujifilm sphincterotome.All six incidents involved the same procedure at the same user facility.The previous five incidents were reported to the fda as 3001722928-2021-00021, 3001722928-2021-00008, 3001722928-2021-00004, 3001722928-2021-00024, and 3001722928-2021-00028.
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Manufacturer Narrative
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Fujifilm corporation conducted the root cause investigation that was concluded on (b)(6) 2022.During the investigation, it was identified that high-frequency devices were used with and without visualizing the proximal end of the wire on the endoscope monitor.As a result, the wire came in contact with the distal end metal part of the endoscope, causing a high-frequency current to flow through the distal end metal part.A burn can occur if the energized distal end metal part comes into contact with the mucosa.The relevant warnings are included in the ifu of ed-580xt and it is probable that user did not comply with these warnings.Unlike high-frequency devices, the distal end metal part has a large area, so it does not cut deeply and only superficial mucosal burns may occur.None of the seven (7) burns reported by fujifilm were serious injuries.Therefore, fujifilm believes that it will not lead to a serious injury.
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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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