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

Model Number	KD-V411M-0720
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the power of the single use 3-lumen sphincterotome was not turned during the first use when used with an electrosurgical unit.The issue occurred during a therapeutic procedure.There were no abnormalities in the appearance of the knife wire.Another device was used and the procedure was completed.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the wire sheathing was torn and the knife wire was exposed.The tip of the knife was burnt.There were no problems with conductivity between the knife and the control plug and no problems with the connection.Electricity was able to be conducted without problems.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the torn coating could not be determined, likely factors causing the tear could have been the following: - the knife wire was deformed and the coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.- 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.Since the issue could not be reproduced and there was no conductivity problems, a definitive root cause of the output failure could not be determined.The presence of black charring on the knife wire suggests that it was not totally in a state of no energization.Possible reasons for failure to energize include the following factors: - insufficient connection between the plug and a-cord or between the a-cord and the hf ablation power supply.- the contact area between the tissue (incision target) and the tip of the knife wire was large, and the high-frequency current density was low, so it felt as if the power was not energized.- foreign objects adhered to the knife wire during the incision.- the target area was immersed in a liquid such as mucus.In addition, the coated portion of the knife wire was peeled off, which may have caused current leakage from the exposed wire, resulting in reduced output.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : - 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 cutting wire 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.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of 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: 18533928
• Report Number: 9614641-2024-00129
• Device Sequence Number: 7587958
• Product Code: KNS
• UDI-Device Identifier: 04953170382628
• UDI-Public: 04953170382628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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: Health Professional
• Device Model Number: KD-V411M-0720
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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