MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0730
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the sphincterotome exhibited the covering of the knife wire was peeled and dislodged, the coated portion of the cutting wire was torn and the broken portion was scorched and melted.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A definite root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: force might have applied to the coated portion of the cutting wire when the device was withdrawn from endoscope after the coated portion of the cutting wire has torn.This might have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.A likely factor causing tears 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 has possibly been rubbed due to the effect of contacting a metal area of the endoscope.The cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised, an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.A review of the device history record found no deviations that could have caused or contributed to the reported issue 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 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN 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: 21333901
• Report Number: 9614641-2025-00125
• Device Sequence Number: 3771856
• Product Code: KNS
• UDI-Device Identifier: 04953170380594
• UDI-Public: 04953170380594
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: Other
• Device Model Number: KD-V411M-0730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/07/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown