MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; DUODENOVIDEOSCOPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.

Event Description

On november 12, 2020, olympus medical systems corp.(omsc) received literature titled ""original article level of total bilirubin in the bile of the future remnant liver of patients with obstructive jaundice undergoing hepatectomy predicts postoperative liver failure"".The purpose of the literature was to investigate whether the daily level of total bilirubin in the bile (ltb) excreted from the future remnant liver (frl) can predict post-hepatectomy liver failure (phlf) in patients with obstructive jaundice undergoing hepatectomy.Seventy-four patients with perihilar cholangiocarcinoma (n = 58) or gallbladder cancer (n = 16) were included.All patients underwent right hepatectomy or right trisectionectomy or left trisectionectomy and/or caudate lobectomy with bile duct resection after biliary drainage at our institute between 1994 and 2016 at tokyo women's medical university.In the literature, it was reported that 5 postoperative infections after biliary drainage and collection of bile juice from the frl and right hepatectomy or right/left trisectionectomy with bile duct resection was observed.These five patients also had phlf, three of five patient died of phlf and the other two discharged.The procedure of biliary drainage and collection of bile juice from the frl was performed using an endoscopy (olympus; jf-260v, tjf-240, or jf-240).It was not found what the model number of the endoscopy the surgeon used each other.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, omsc assumed that 5 infections might be associated with the duodenovideoscope.Therefore, omsc will submit 5 medical device reports (mdr) for 5 postoperative infections of the duodenovideoscope.This report is 3 of 5 reports for 5 postoperative infections of the 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: 10910239
• MDR Text Key: 218502354
• Report Number: 8010047-2020-09498
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 11/26/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR