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	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.The subject device was manufactured on september 2022 based on the provided lot information.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Based on the device evaluation, it is likely this single-use sphincterotome was used multiple times.There were no reports of patient involvement.
Event or Problem Description
Additional information from the customer stated that the procedure was therapeutic with no delay and was completed without patient injury nor harm.
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, the event (reused disposable products) was confirmed, and the device did not meet the standard specifications.It was determined that the suggested event was caused by device handling.The device was inspected and was found to have been used, which was suggestive of black colored wire that was intact.At bow position (pulled), the wire was straight and in correct position.While attempting de-bowing the wire came out of the plane of the sheath, which was determined to be due to excessive push.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: (drawing no.Gk6226 revision no.13): ·do not attempt to sterilize the instrument.Doing so could pose an infection control risk, cause tissue irritation, equipment damage, or malfunction.·the instrument is a single-use, disposable item.Do not reuse or attempt to sterilize it.Reusing the instrument could pose an infection control risk, cause tissue irritation or malfunction.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: 19015638
• Report Number: 9614641-2024-00811
• Device Sequence Number: 15494479
• Product Code: KNS
• UDI-Device Identifier: 04953170184017
• UDI-Public: 04953170184017
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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-0720
• Device Lot Number: 29K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/26/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown