FDA Adverse Event Injury Summary report: N

EVIS EXERA III DUODENOVIDEOSCOPE

MDR report key: 21785841 · Received April 7, 2025

Report

Report Number
MW5168652
Event Type
Injury
Date Received
April 7, 2025
Date of Event
May 5, 2023
Report Date
April 4, 2025
Manufacturer
OLYMPUS/AIZU OLYMPUS CO., LTD.
Product Code
FDT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THE MODEL # TJF-190V, SERIAL # (B)(6) WAS INTRODUCED THROUGH THE MOUTH, AND ADVANCED TO THE DUODENUM AND USED TO INJECT CONTRAST INTO THE BILE DUCT. THE ERCP WAS TECHNICALLY DIFFICULT AND COMPLEX DUE TO EQUIPMENT MALFUNCTION. THE PATIENT TOLERATED THE PROCEDURE WELL. CO2 USED. A BILIARY STENT WAS VISIBLE ON THE SCOUT FILM. TWO STENTS WERE REMOVED FROM THE COMMON BILE DUCT USING A SNARE. ONE 8.5 FR BY 5 CM TEMPORARY STENT WITH A SINGLE EXTERNAL FLAP AND A SINGLE INTERNAL FLAP WAS PLACED 4.5 CM INTO THE COMMON BILE DUCT. BILE FLOWED THROUGH THE STENT. THE STENT WAS IN GOOD POSITION. AS A SECOND STENT WAS BEING INSERTED THERE WAS AN ISSUE. I NORMALLY TAKE THE RAD MARKER TO THE BIFURCATION AND THEN WITHDRAW THE INSERTER. AS I LIFTED THE ELEVATOR TO FINISH THE INSERTION, THE ENTIRE DEVICE LUNGED FORWARD INTO A PERIPHER DUCT. THIS ENTRAPPED THE WIRE AND AS THE DEVICE WAS BEING WITHDRAWN, THE MARKER RING CAME OFF IN THE DUCT. THE WIRE WAS LOCKED, AND LOCATION COULD NOT BE KEPT MULTIPLE ATTEMPTS TO GET BACK INTO THE SAME DUCT WERE NOT SUCCESSFUL. I HAVE PLACED A CALL TO DR. (B)(6) AT (B)(6) TO DISCUSS. ONE 8.5 FR BY 5 CM TEMPORARY STENT WITH A SINGLE EXTERNAL FLAP AND A SINGLE INTERNAL FLAP WAS PLACED 4.5 CM INTO THE COMMON BILE DUCT. BILE FLOWED THROUGH THE STENT. THE STENT WAS IN GOOD POSITION. I AM EMAIL TO FILE A COMPLAINT BECAUSE OF A PIECE OF EQUIPMENT BROKE OFF INSIDE OF ME AND THE DOCTORS STILL CAN¿T GET IT OUT. I HAD AN ERCP DONE. I AM ATTACHING THE REPORT FROM MY DOCTOR AFTER SURGERY. I HAVE HAD MANY SURGERIES AFTER THAT TO TRY AND REMOVE IT AND IT¿S UNSUCCESSFUL. HERE IS MY PHONE NUMBER (B)(6). REF REPORT: MW5168653.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1454007 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT OLYMPUS/AIZU OLYMPUS CO., LTD. TJF190V-5139

Patients

Seq Age Sex Outcome Treatment
1 47 YR Unknown BILIARY STENT (805 FR BY 5 CM)