MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0720

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

Patient Problem Inflammation (1932)

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.Based on the reported event, it is presumed that the reported complication was not due to the malfunction of the device.

Event Description

On april 21, 2020, olympus medical systems corp.(omsc) received literature titled ¿endoscopic sphincterotomy to prevent post-ercp pancreatitis in patients with biliary neoplasms: a multicenter retrospective cohort study¿.In the literature, it was reported that seven patients developed severe post-ercp pancreatitis (pep).The severe pep was defined as over 10 days of hospital treatment, surgical or intensive treatment, or where pep contributed to the death of the patient.The literature indicated that papillotomy knife (clevercut, kd-v411m-0720), 3d-idus probe (um-dg20-31r), and biopsy forceps (fb-38w or fb19n-1) might be used for the procedure.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Therefore, omsc will submit 3 medical device reports (mdr) for every type of the device.This report is 1 of 3 reports for severe pep of kd-v411m-0720.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN SPHINCTEROTOME
• 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: 10055420
• MDR Text Key: 196200718
• Report Number: 8010047-2020-02698
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2020

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: Health Professional
• Device Model Number: KD-V411M-0720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/14/2020
• 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