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

Model Number	KD-V611M-07251S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the sphincterotome insulation detaches from the cutting wire.The issue occurred during therapeutic ercp (endoscopic retrograde cholangiopancreatography) procedure.The procedure was not completed.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction based on the legal manufacturer's final investigation.Based on the information provided from the investigation, it was confimed that the cutting wire was not broken, and the coated portion of the cutting wire was torn.A likely mechanism causing the tear of the coated portion of the wire might be the following: 1.The slider was pushed more than needed causing the cutting wire to deflect.2.The deflected coated portion of the cutting wire and the metal part of the distal end of the endoscope came into contact when the forceps elevator was raised.3.The tube was moved back and forth causing the metal part of the distal end of the endoscope to scratch the coated portion of the wire.As a result, the coated portion of the wire was ruptured.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20273863
• Report Number: 9614641-2024-01874
• Device Sequence Number: 11630399
• Product Code: KNS
• UDI-Device Identifier: 04953170403088
• UDI-Public: 04953170403088
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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-V611M-07251S
• Device Lot Number: 36V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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