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

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

Patient Problem 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 lot 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 january 14, 2021, olympus medical systems corp.(omsc) received literature titled "source: japan endoscopy database (jed) project: a multicentre registry database of endoscopic retrograde cholangiopancreatography-related procedures".The purpose of the literature was to evaluate a multi-centre ercp-related procedure data registration system.In the literature, it was reported that 3 serious infections were observed of 4104 patients experienced ercp at kitasato university, saitama medical university international medical center, toranomon hospital and jikei medical university katsushika medical center between january 1, 2015 and march 31, 2017.The procedure of ercp was performed using an endoscopy (olympus; gf-uct260, tjf, jf, sif, pcf).It was not found what the model number of the endoscopy the surgeon used.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 3 serious infections might be associated with the duodenovideoscope.Therefore, omsc will submit 3 medical device reports (mdr) for 3 serious infections of the duodenovideoscope.This report is 2 of 3 reports for 3 serious 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: 11264570
• MDR Text Key: 233161870
• Report Number: 8010047-2021-02120
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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
• Date Manufacturer Received: 01/14/2021
• 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