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 Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device kd-v411m-0725 was returned for evaluation.The lot number was 18k with supplementary information number of ¿26¿.(m-bc manufacture date: august 26, 2021).Device evaluation, the following were noted: the cutting wire was broken.The broken portion was scorched and melted.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.The outer diameter of the cutting wire measured.The result indicated no abnormalities.The length of the cutting wire and the coated portion measured.The distal side of the coated portion was missing approximately 6.5-8.5 mm.Other abnormalities that could lead to the breakage of the cutting wire were not confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Length of cutting wire.Length of coated portion.Operation of cutting wire.The instruction manual (drawing no.Gk6224, revision no.8) contains the following information.Therefore, it would be possible to prevent this event from occurring.Since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.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.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.Based on the confirmation result and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.The cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised.The output was activated, the cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised, and the cutting wire became hot instantly.This caused the cutting wire to break.Investigation is ongoing.This report will be supplemented accordingly following investigation completion.

Event Description

It was reported that the clever cut knife broke during an est (endoscopic sphincterotomy) procedure.It is unknown whether it occurred during high frequency output.The device was replaced with similar device and the intended procedure was completed.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The tear on the coated portion of the cutting wire was reproduced.It was thought that the tear 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 inferred from the investigation that a force was applied to the coated portion of the cutting wire when the device was withdrawn from endoscope (after the coated portion of the cutting wire had torn).This may have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.A definitive root cause for the reported product problem was not established.

• 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: 13782056
• MDR Text Key: 287256648
• Report Number: 8010047-2022-04503
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382635
• UDI-Public: 04953170382635
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0725
• Device Lot Number: 18K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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