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

Model Number	KD-VC611Q-07301S
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the cutting wire protection of the single use preloaded sphincterotome was on the distal part of the device and the therapeutic sphincterotomy was unable to be performed.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the coated portion of the cutting wire was ruptured and it was displaced to the distal end of the cutting wire.The cutting wire was scorched and melted.The total length of the coated portion of the cutting wire was measured and no abnormalities were found.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the torn coating could not be determined, likely factors causing the tear could have been the following: 1 - the forceps elevator of the endoscope was being up.2 - when the cutting wire deflected, the coated portion of the cutting wire, and the metal part of the distal end of the endoscope came into contact.3 - the cutting wire was moved back and forth in state ¿no.2¿ description.This caused the coated portion of the cutting wire to tear.As a result, the cutting wire partially exposed.4 - the metal tip of the endoscope and the exposed cutting wire came into contact, leading to an electrical discharge during energization.5 - the coated portion of the cutting wire ruptured due to the description ¿no.4¿.As a result, when the cutting wire was inserted to or retracted from duodenal papilla, the coated portion of the cutting wire displaced to the distal end.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following 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.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE PRELOADED 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: 18710522
• Report Number: 9614641-2024-00379
• Device Sequence Number: 7256407
• Product Code: KNS
• UDI-Device Identifier: 04953170371332
• UDI-Public: 04953170371332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141991
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2024

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-VC611Q-07301S
• Device Lot Number: 04V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• 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: 06/09/2020
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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