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Model Number ED-580XT
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
Rn, gi lab manager.The scope was requested for return for instrument inspection.Fujifilm corporation conducted a reproduction experiment using the same model trocar and duodenoscope.It was found that if the distal end cap was either improperly attached, or the bending portion of the duodenoscope was not straight.The cap may get caught on the edge of the trocar and detach.The investigation is in progress.It should be noted that the operation manual indicates the insertion route as peroral, however, the endoscope was inserted using a trocar via surgical incision.If any additional relevant information is provided, a supplemental report will be submitted.
Event Description
On july 07, 2020 fujifilm medical systems usa inc (fmsu) was informed that the distal end cap (dc-07d) prematurely detached from the distal end of a duodenoscope at the end of a procedure; fujifilm corporation was notified of the event on (b)(6) 2020.The procedure being performed was an endoscopic retrograde cholangio-pancreatography (ercp) for removal of gallstones from the lower third of the bile duct.The ercp was done laparoscopically with the scope being inserted through a non-fujifilm 15mm trocar via the abdomen.At the end of the procedure as the physician was withdrawing the scope, the distal end cap came off the scope and was observed to be stuck on to the trocar.The distal end cap was removed and discarded.The customer did not indicate any issues during attachment of the distal end cap prior to start of the procedure.This procedure was delayed an unspecified amount of time; however it did not result in any adverse issues for the patient and the procedure was completed successfully.This report is being submitted in abundance of caution.
Manufacturer Narrative
Updated information is being provided in section h6 (type of investigation, investigation findings, investigation conclusions), h10 (narrative).The endoscope was returned to fujifilm medical systems u.S.A., inc (fmsu) on september 19, 2020, and the inspection was concluded on september 21, 2020.The results of the inspection did not reveal any abnormality that could have led to the failure of distal cap becoming detached.The operation manual indicates the insertion route as peroral, however the endoscope was inserted using a trocar via surgical incision.The scope will be serviced according to device specifications and returned for clinical use.If any additional relevant information is provided, a supplemental report will be submitted.
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Brand Name
Type of Device
Manufacturer (Section D)
798 miyanodai kaisei-machi
kanagawa, 00258 8538
JA  002588538
MDR Report Key10542398
MDR Text Key249650003
Report Number3001722928-2020-00014
Device Sequence Number1
Product Code FDT
UDI-Device Identifier14547410359289
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberED-580XT
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/22/2020
Initial Date FDA Received09/16/2020
Supplement Dates Manufacturer Received09/21/2020
Supplement Dates FDA Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1