MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE CANNULA V; SINGLE USE BILIARY STENT

Model Number PR-V220Q

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

Patient Problems Intraoperative Pain (2662); No Code Available (3191)

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 is no description of the device's malfunction.

Event Description

On september 23, 2020, olympus medical systems corp.(omsc) received literature titled "a comparative evaluation of treatment methods for bile duct stones after hepaticojejunostomy between percutaneous transhepatic cholangioscopy and peroral, short double-balloon enteroscopy".This study was conducted the endoscopic lithotomy for the bile duct stones after hepaticojejunostomy on 40 patients between october 2001 and may 2013.The subject device, basket, cholangioscopy, and guidewire were used during the procedure.In the literature, it was reported that complications of cholangitis, hemobilia, uncontrollable severe pain resulting in the discontinuation of treatment, severe pain necessitating analgesic administration, and transplanted liver graft ischemia have occurred.There are no descriptions of device relevance for all adverse events in the literature.Based on the available information, detailed information of the subject device was not provided.Whereas, omsc assumes that the uncontrollable severe pain resulting in the discontinuation of treatment was related to the subject device due to occurred during the procedure.Therefore, omsc will submit one medical device report (mdr) for uncontrollable severe pain resulting in the discontinuation of treatment of the subject device.

• Brand Name: SINGLE USE CANNULA V
• Type of Device: SINGLE USE BILIARY STENT
• 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: 10703427
• MDR Text Key: 212327414
• Report Number: 8010047-2020-07891
• Device Sequence Number: 1
• Product Code: ODD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950729
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PR-V220Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other