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

Model Number	KD-V431M-0730
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
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 sphincterotome exhibited the cover was peeled and the knife was exposed.There were no reports of patient involvement.
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 confirmation of the device and the investigation results in the past, a likely factor causing tears of the coated portion of the cutting wire might be the following: - 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.(see fig.5.6) - it can be inferred that some kind of force might have applied to the coated portion of the cutting wire when the device was withdrawn from endoscope after the coated portion of the cutting wire has torn.This might have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.However, the exact cause of the reported event could not be identified.The subject event can be detected and prevented by implementing in accordance with the below instructions for use (ifu): ¿ do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.¿ do not insert the instrument into the endoscope when the cutting wire is tightened.Doing so may extend the distal end of the insertion portion from the endoscope tip abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.¿ when inserting the instrument into the endoscope, hold the slider firmly.Otherwise, the distal end of the insertion portion may bend and could extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope or instrument.¿ do not advance or extend the instrument abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.¿ when inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.¿ insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.¿ do not pull the slider abruptly, or the distal end of the insertion portion will bend rapidly.This could result in patient injury, such as perforations, bleeding, or mucous membrane damage.¿ do not tighten the cutting wire more than necessary, and do not force it against the papilla of vater.This could result in patient injury, such as perforations, bleeding, or mucous membrane damage.¿ 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 you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion.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: 20185575
• Report Number: 9614641-2024-01806
• Device Sequence Number: 8363916
• Product Code: KNS
• UDI-Device Identifier: 04953170184192
• UDI-Public: 04953170184192
• 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): 10/17/2024

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-V431M-0730
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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