MAUDE Adverse Event Report: Olympus Vietnam Co. Ltd. Single Use Preloaded Sphincterotome V

Model Number	KD-V611M-07302S
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the the cutting wire of the sphincterotome reportedly split and subsequently broke during the application of electrical current and its axis to rotated to the left and creating a potential risk of perforation.The issue occurred during a therapeutic endoscopic retrograde cholangiopancreatography procedure.Additional information received there was no perforation.The patient is doing very well and has already been discharged home.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The most probable cause of the complaint is, cause not established.Which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.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): Olympus Vietnam Co. Ltd.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• Manufacturer (Section G): Olympus Vietnam Co. Ltd.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50847297
• Report Number: 3008040402-2026-00319
• Device Sequence Number: 18626006
• Product Code: KNS
• UDI-Device Identifier: 04953170403149
• UDI-Public: 04953170403149
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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-07302S
• Device Lot Number: 66V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2026
• 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