MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number UNKNOWN (TJF-Q180VOR TJF-160VR)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp(omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.There was no malfunction report of the subject device concerning the events.The exact cause could not be determined.

Event Description

On june 20, 2018, olympus medical systems corp.(omsc) received a literature titled ¿complete endoscopic sphincterotomy with vs.Without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study¿(karsenti david et al.Endoscopy 2017; 49: 968¿976).The literature compared ¿sphincterotomy with large-balloon dilation for the removal of large bile duct stones¿ (eslbd group) and ¿sphincterotomy without large balloon dilation¿(conventional group).The literature reported the multi-center study result of procedures for 150 patients having bile duct stones more than 13mm in size between 2010 and 2015.In the procedures, following duodenoscopes were reportedly used.Olympus dunodenovideoscopes tjf-160vr or tjf-q180v in 17 endoscopy units.Non-olympus duodenovideoscopes in 4 endoscopy units.In the literature, following 12 cases of complications in 11 patients were reported; bleeding (5 cases); for two patients in the conventional group ,no blood transfusion was required and bleeding could be managed conservatively (in one case with placement of a biliary covered stent).Post-ercp bleeding was reported in three patients in the eslbd group: one patient did not require a blood transfusion, one patient received 2 units of blood, and the third patient required 8 units of blood, placement of a biliary stent, and a 22-day hospital stay.Acute pancreatitis (1 case); the condition finally resolved following medical care and a 19-day hospital stay.Perforation (1 case); one case of perforation was recorded in the same es-lbd patient who had presented severe bleeding and was treated with biliary stenting.This pneumoretroperitoneum was diagnosed on day 1 by ct and resolved on day 7.Post operation cholangitis (2 cases); death(3 cases); none of the deaths were related to the ercp procedure.One patient in the conventional group died from cerebral vascular disease 5 days post-ercp, and another patient died as a result of myocardial infarction and cerebral vascular disease 21 days post-ercp.The es-lbd patient died from cardiac failure 24 hours post-ercp.Since there was no information on the model of the dunodenovideoscope that was used in each cases, omsc is submitting eight mdrs according to the number of patients having complications (except for 3 death cases since the literature stated there was no relationship between the consequence and the ercp).This is one of eight reports.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7701571
• MDR Text Key: 114406053
• Report Number: 8010047-2018-01362
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN (TJF-Q180VOR TJF-160VR)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other