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

Model Number KD-V411M-0320

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

The customer reported that their olympus single use 3-lumen spincterotome v had coating material peeling off while the unit was inside the patient.According to the initial reporter, they removed the defective device and successfully completed the procedure with using another unit.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus.However; investigation is ongoing.During the initial evaluation, the user's report was confirmed.While being examined under a microscope, it was found the sections of the coating on the cutting knife were damaged.A portion of the coating appears to be missing, and was not returned with the rest of the subject device.Other parts of the coating were torn and not covering the cutting knife properly.However, no crushed areas, kinks, or excessive bends were found in the rest of the device.The distal end was intact with no indications of physical damage.If additional information becomes available following the device evaluation, a supplemental report will be filed.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported device problem.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for the reported product problem was not established.However, it was probable that the issue occurred according to the following mechanism: 1.The forceps elevator of the endoscope was raised.2.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.3.As described in (2), the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.Additionally, the slider was pushed more than needed.This caused the cutting wire to deflect.It was thought that a force may have been applied to the coated portion of the cutting wire when the device was withdrawn from the endoscope (after the coated portion of the cutting wire had torn).This might have caused the coated portion of the cutting wire to detach from the cutting wire.The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following: ¿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.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.¿ olympus will continue to monitor field performance for this device.

• 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: 14138081
• MDR Text Key: 298825203
• Report Number: 8010047-2022-06560
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382604
• UDI-Public: 04953170382604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0320
• Device Lot Number: 1YV 22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1