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

Model Number	KD-VC631Q-07203S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) at the time of the sphincterotomy during bowing, the wire of the single use preloaded sphincterotome broke at the ampulla inside the patient in the scope.
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.It has been less than 1 year, since the subject device was manufactured.Based on the results of the investigation, the reported issue (broken cutting wire) was likely, due to the following mechanism: 1) the device was energized in one of these following situations: (a) the cutting wire was in point contact with tissue or they were close to each other.(b) the cutting wire was in point contact with the distal end of endoscope or they were close to each other.2) an electrical discharge, occurred in the cutting wire.And the cutting wire became hot instantly.3) the cutting wire was broken.However, the root cause could not be determined.The event can be detected/prevented, by following the instructions for use (ifu), which state: 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.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.This supplemental report includes a correction to d8 to provide information.That was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PRELOADED 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19244241
• Report Number: 9614641-2024-01032
• Device Sequence Number: 17884537
• Product Code: KNS
• UDI-Device Identifier: 04953170371738
• UDI-Public: 04953170371738
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: Health Professional
• Device Model Number: KD-VC631Q-07203S
• Device Lot Number: 3XV
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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: Female
• Patient Weight: 70 KG
• Patient Race: White