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 Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
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 observed, during the device inspection.That the single use 3-lumen sphincterotome exhibited cover peeling off.There were no reports of patient involvement.
Additional Manufacturer Narrative
The lot# in the initial medwatch was 3yk with supplementary information number of: 3yk13.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information is added to the following fields: h3, h4 and h6.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Evaluation found the coated portion was partially torn, and the cutting wire was exposed.The missing of the coated portion was not observed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be 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 event can be prevented by following the instructions for use which state: 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 wire cutting 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.Be sure that the rear end of the cutting wire extends from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20196188
• Report Number: 9614641-2024-01816
• Device Sequence Number: 20520600
• Product Code: KNS
• UDI-Device Identifier: 04953170184055
• UDI-Public: 04953170184055
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: Other
• Device Model Number: KD-V411M-0730
• Device Lot Number: 3YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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