MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE PRELOADED SPHINCTEROTOME

Model Number	KD-VC412Q-0215
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the single use sphincterotome v (distal wireguided) was inspected before use and the covering was torn, exposing the knife wire.The issue was found during procedure, and the therapeutic procedure (endoscopic sphincterotomy) was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation of covering was torn, exposing the knife wire was confirmed.Device evaluation found that the end face of the coated portion was torn, and the cutting wire was slightly exposed.The coated portion was not missing.Based on the investigation result, a likely factor causing peeling of the coated portion of the cutting wire might be the following.However, the exact cause could not be determined.It is possible that the slider was slightly pushed causing the cutting wire to deflect.The coated portion of the cutting wire had possibly been rubbed due to the effect of contacting a metal area of the endoscope.This issue is addressed in the instructions for use (ifu): 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.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED 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: 17612540
• Report Number: 9614641-2023-01229
• Device Sequence Number: 20682480
• Product Code: KNS
• UDI-Device Identifier: 04953170399336
• UDI-Public: 04953170399336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: KD-VC412Q-0215
• Device Lot Number: 32V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown