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

Model Number	KD-V431M-0720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a therapeutic endoscopic papillotomy, the knife broke during cutting (during output).The wire did not fall off.The device was replaced with similar device and the intended procedure was completed with no harm or injury to the patient.No user injury reported.
Additional Manufacturer Narrative
The lot number was 23k with supplementary information number of ¿07¿.(m-bc manufacture date: mar 7, 2022) reported issue: the cutting wire was broken.Investigation was carried out to confirm the broken portion.Device evaluation found the broken portion was scorched and melted.In investigation performed in the past, a coated portion damage was duplicated by heat generation due to an electrical discharge.Shape of the coated portion of the subject device was similar to the shape confirmed in the past investigation result.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.The length of the coated portion of the cutting wire, and the cutting wire itself presented no abnormalities.There were no missing parts in the subject device.Other abnormalities that could lead to the breakage of the cutting wire were not confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities found from the device history record of the following items, which related to the reported phenomenon.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.-process inspection sheet -quality inspection sheet -nonconforming product report this instruction manual (drawing no.Gk6224, revision no.9) contains the following information.Therefore, it would be possible to prevent this event from occurring.Since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.Do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together.This could burn the tissue and/or damage the endoscope or the instrument.Based on the results of confirmation of the device and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.1.The device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.2.Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other.3.The output was activated in state of ¿2¿ description.This might have led to an electrical discharge between the cutting wire and the distal end of the endoscope.4.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That might have caused the cutting wire to break.It can be inferred that heat generated by an electrical discharge caused damage of the coated portion.Olympus will continue to monitor complaints for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction.Section d4 was corrected with information that was inadvertently left out of the initial report.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15554494
• Report Number: 9614641-2022-00426
• Device Sequence Number: 6584646
• Product Code: KNS
• UDI-Device Identifier: 04953170380631
• UDI-Public: 04953170380631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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-V431M-0720
• Device Lot Number: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIO300.
• Patient Sex: Unknown