MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V manufactured by Olympus Medical Systems Corp..
[105185731]
Patient Sequence No: 1, Text Type: N, H10
[105185732]
Endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy, placement of 7 fr x 12 cm biliary stent in the common bile duct and cholangiogram operative report: initially tried to place a 10-french stent, but unfortunately, the elevator broke on our scope as we were attempting to maneuver. We then had to switch to a 7-french stent, which i was able to place without the assistance of the elevator. Elevator on all department ercp scopes have been modified by olympus. Broke during procedure. Olympus ercp scope model # tjf 180. From procedure: "initially, a 0. 035 guidewire was passed into what was thought was the pancreas, but the wire was moving in an unusual configuration. We performed a very limited pancreatogram through the major papilla, which demonstrated what i had been suspicious of, that the patient had incomplete pancreas divisum. She had an ansa loop in the ventral pancreatic duct, which then terminated abnormally short. There was, however, filling of the dorsal pancreatic duct as a result, which showed the incomplete divisum. We actually were able to place a wire relatively deep into the ventral pancreatic duct despite her incomplete divisum by maneuvering it around the ansa loop and we were able to use this to cannulate the biliary tree with a double-wire cannulation. The biliary tree came off at a very acute angle, but we were able to advance a 0. 035 guidewire up into this area. We then performed a cholangiogram. Cholangiogram demonstrated a normal distal biliary tree; although, it did taper a bit at the ampulla. The cystic duct filled as did the gallbladder. At the hilum, which was abnormally low, likely due to pressure from the patient's tumor, we did note that there was a complex stricture. The right hepatic duct came off and 2 separate biliary segments on that side appeared to coincide with the same strictured area and did drain together. There was dilation of the right side. The left side was, however, minimally dilated, if at all, and we were not able to easily enter the left side. Despite the use of multiple wires and multiple devices, we were not able to cannulate the left side. Decision was then made to place a unilateral stent in order to perhaps facilitate cannulation to make sure that the right side drained. We initially tried to place a 10-french stent, but unfortunately, the elevator broke on our scope as we were attempting to maneuver. We then had to switch to a 7-french stent, which i was able to place without the assistance of the elevator. The patient had a 7-french, 12 cm stent placed into her right biliary system, terminating in the duodenum with prompt drainage of contrast out of the entire right side. We then switched scopes and reintroduced a guidewire into the biliary tree and tried multiple times to, once again, cannulate the left. We were unsuccessful and there was no contrast left on the left side, so i was encouraged that there was either very minimal liver parenchyma left in that area or there really was not much of a stricture. We did, at one point, have the wire proceed into the left side of the liver, which we then followed with a tome, but we were not able to find anything there. I believe that was likely the wire passing into an area of tumor and this was not particularly helpful. We abandoned attempts at the left hepatic duct at that point. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7420911 |
| MDR Report Key | 7420911 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-09 |
| Date of Event | 2017-09-19 |
| Report Date | 2018-04-09 |
| Date Reported to FDA | 2018-04-09 |
| Date Reported to Mfgr | 2018-04-09 |
| Date Added to Maude | 2018-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA II DUODENOVIDEOSCOPE |
| Generic Name | ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM |
| Product Code | NWB |
| Date Received | 2018-04-11 |
| Model Number | TJF-Q180V |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 3500 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-11 |