MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0730

Device Problems Break (1069); Sparking (2595)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the single use 3-lumen sphincterotome knife wire was damaged and sparks occurred.The issue was found during a therapeutic procedure for an endoscopic papillary sphincterotomy.During the procedure the nipple was incised once, and when an additional incision was attempted, the knife wire broke when electricity was applied.The procedure was completed by replacing it with similar equipment.There were no reports of patient harm.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for evaluation and the customer's allegation was confirmed.Based on the results of the investigation, it is likely the knife wire breakage was caused by the following mechanisms: 1.When the forceps stand of the endoscope was raised, the knife wire where the wire coating was torn came into contact with the tip of the endoscope.2.1.When electricity was applied in this state, the knife wire instantly became hot at the contact point, leading to breakage.However, a definitive root cause could not be established.The event can be prevented by following the instructions for use which state: when inserting or removing this product from the endoscope, pull the slider slightly and move the knife wire along the curve of the tube.If the forceps base of the endoscope is moved back and forth with the knife wire bent, the metal part of the forceps base may come into contact with the knife wire and scrape the coating.Do not apply electricity to a torn or scratched wire sheath while it is in contact with tissue.If current is applied to a torn or scratched wire sheath while it is in contact with tissue, current may leak, resulting in decreased output or unintended tissue burns.If you feel that the product is not sharp when energizing it, pull out this product from the endoscope and check that there is no damage such as tears or scratches on the wire sheathing.This instruction manual contains the following information.(drawing no.Gk6224 revision no.9).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.Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.Insufficient output or unintended tissue injury may occur in case the cutting wire contacts the forceps elevator.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): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18169896
• MDR Text Key: 329788729
• Report Number: 9614641-2023-01737
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382642
• UDI-Public: 04953170382642
• 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
• Report Date: 11/20/2023

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-0730
• Device Lot Number: 18K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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
• Treatment: VIO300D