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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the sphincterotome cutting wire did not return to its original position.The issue occurred during preparation for use in a therapeutic endoscopic cholangiography procedure.The procedure was delayed by 18 minutes and completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final 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 because the device was discarded, the definitive root cause of the cutting wire issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "before use, prepare and inspect the instrument and a cord as instructed below.Should any irregularity be observed, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforations, bleeding, mucous membrane damage, thermal injury and may result in more severe equipment damage.Do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.Do not move the slider rapidly.This could damage the instrument.Do not stretch the cutting wire too tightly.This could damage the instrument.The distal end of this instrument has been pre-curved.Curve the distal end further or in a different direction if necessary." 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: 19069687
• Report Number: 9614641-2024-00876
• Device Sequence Number: 6826007
• Product Code: KNS
• UDI-Device Identifier: 04953170183973
• UDI-Public: 04953170183973
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: ACC-EM-31K-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2023
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic