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

Model Number	KD-V411M-0320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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 reported that the subject device knife wire was not facing the 11 o'clock direction.The issue occurred during a therapeutic unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Please also see section b5 updates obtained from customer follow up response.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection and the reported failure was confirmed.Device evaluation found cable damage.Based on investigation results, it was assumed that a cable failure caused a communication failure, and the images were not displayed.A definitive root cause of cable failure could not be identified.As per instruction for use (ifu), it states: chapter 4 operation(warning) ·if an abnormal endoscopic image/function occurs and returns to its normal condition by itself, the equipment has malfunctioned.Continued use in such condition may cause abnormality again and it may not be able to recover to normal condition.In this case, immediately stop use and withdraw the endoscope from the patient slowly.Continued use of such equipment may cause patient injury, bleeding and/or perforation.·if the endoscopic image on the video monitor should unexpectedly disappear or freeze during a procedure and cannot be restored, turn the video system center off and then on again.If the image still does not appear, immediately turn the video system center off.Disconnect the camera head from the endoscope and carefully withdraw the endoscope from the patient, while viewing through the endoscope¿s eyepiece.In addition, be sure to prepare another camera head to avoid interruption of the procedure.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on feedback from the field.The event occurred during endoscopic sphincterotomy (est).

• 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: 20363675
• Report Number: 9614641-2024-01920
• Device Sequence Number: 14401867
• Product Code: KNS
• UDI-Device Identifier: 04953170382604
• UDI-Public: 04953170382604
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024

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-0320
• Device Lot Number: 43V 06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 10/30/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/16/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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