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

Model Number KD-V411M-0725

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

Patient Problem Burn(s) (1757)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical system corp. (omsc) for investigation. As a result of the investigation, omsc confirmed that the device could apply current normally. As a measurement result of the resistance value between the knife wire and the plug of the operation part, there was no anomaly. The coating on the cutting wire was torn. The device history record for the lot indicated no abnormality with the event-related items below. Appearance of the pfa coating part on the cutting wire. Dc resistance value of the cutting wire. This type of event is most likely related to the operator¿s technique. Based on the past similar cases, omsc assumes that this event occurred because the coating on the cutting wire was torn. The coating on the cutting wire was torn and the cutting wire was exposed. The exposed cutting wire contacted the non-target tissue during activation. As a result, burn occurred and the papilla could not be incised with the subject device due to leakage of electric current to the non-target tissue. Omsc assumes that the damage of the coating occurred due to contacting with the metal part of the forceps elevator of the endoscope. The instruction manual of the device has already warned as follows; do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end. If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result. If you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion. When inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube. Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material.

Event Description

During an endoscopic sphincterotomy, the subject device was used. It was reported that the papilla could not be incised with the subject device. The peripheral equipment was replaced with another equipment, and the procedure was completed with the subject device. The physician noticed that the area around the papilla was a condition like burn when retrieving the endoscope. No additional treatment was required. There was no further patient injury reported.

• 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7107165
• MDR Text Key: 94473998
• Report Number: 8010047-2017-01968
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-V411M-0725
• Device Lot Number: 77K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/11/2017 Patient Sequence Number: 1