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

Model Number	KD-VC411Q-0330
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, during a sphincterotomy, the metallic cutting wire on the subject device was cut when energized preventing the possibility of a complementary cut.The sphincterotomy had already been performed correctly but could not be completed with the subject device.The procedure was completed using another similar device.There was no effect on the patient due to the event.
Additional Manufacturer Narrative
The suspect device was not sent to an olympus for evaluation.A review of the device history record found no deviations that could have caused or contributed to the broken wire.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the broken cutting wire was caused by the following: high frequency current being applied between the cutting wire and the tissue at the point of the contact.As a result, the current density at the contact area increased, and the cutting wire became instantly hot.High frequency current was applied when the cutting wire and the tissue were close to each other.As a result, an electrical discharge occurred, and the cutting wire became instantly hot.High frequency current was applied when the distal end of the device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.As a result, an electrical discharge between the cutting wire and the distal end of the endoscope occurred, and the cutting wire became instantly hot.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the cutting wire is very short, the output is too high or activated while the cutting wire touches metal parts of the endoscope, or the cutting wire is tightened too strong.When the cutting wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the cutting wire will be pushed out toward the papilla or move sideways.If the cutting wire breaks off, stop the output immediately and pull the slider completely to retract the broken cutting wire into the tube.Then withdraw the sphincterotome from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct, and/or damage of the endoscope could result." "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." "do not activate output while the torn or damaged coated portion is in contact with the forceps elevator.Such activation could break the cutting wire at the tear or damage of the coated portion.It may also cause the coated portion to drop into the body." "when activating output, set the output mode of the electrosurgical unit to ¿cut¿ or ¿blend¿.Activating output in the ¿coagulation¿ mode could break the cutting wire." olympus will continue to monitor field performance for this device.

• 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: 16188244
• Report Number: 9614641-2023-00070
• Device Sequence Number: 7049079
• Product Code: KNS
• UDI-Device Identifier: 04953170399305
• UDI-Public: 04953170399305
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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-0330
• Device Lot Number: V2520
• 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: 10/10/2022
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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