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

Model Number	KD-VC611Q-07301S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was not confirmed.However, the following reportable malfunction was identified during the device evaluation: the coated portion of cutting wire was torn.Based on the results of the investigation, and since the customer reported malfunction was not reproduced, a root cause could not be identified.Based on the results of the investigation, a root cause for the malfunction identified during the device evaluation could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the cutting wire on the sphincterotome broke when it was tightened.The event occurred during an endoscopic retrograde cholangiopancreatography (ecrp).There were no reports of patient harm.

• 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: 22149987
• Report Number: 9614641-2025-00905
• Device Sequence Number: 8478576
• Product Code: KNS
• UDI-Device Identifier: 04953170399404
• UDI-Public: 04953170399404
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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-VC611Q-07301S
• Device Lot Number: 43V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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