MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE PRELOADED SPHINCTEROTOME

Model Number	KD-VC411Q-0320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the wire coating was torn, and the broken part was burnt and melted.When the outer diameter of the knife wire was measured, no abnormalities were found.Also, no problems with the length of the knife wire or other defects were found.This report is also being submitted 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 definitive root cause of knife wire breakage could not be determined.Considerations ¿ based on the result of confirmation of the device, and the result of past similar complaint investigation, a likely mechanism causing the cutting wire breakage might be the following: 1.The cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised.2.Under circumstances an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.A likely factor causing tears of the coated portion of the cutting wire might be the following.However, the exact cause could not be determined: 1.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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus the single use sphincterotome v (distal wireguided) the knife wire was cut at the timing of energization.The reported issue occurred during a therapeutic biliary endoscopic sphincterotomy (est) procedure.The procedure was subsequently completed with a similar device.There was no patient/user harm or injury reported due to the event.

• Brand Name: SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED 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: 17793934
• Report Number: 9614641-2023-01369
• Device Sequence Number: 6252751
• Product Code: KNS
• UDI-Device Identifier: 04953170371073
• UDI-Public: 04953170371073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2023

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-VC411Q-0320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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 Sex: Unknown