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

Model Number	KD-VC611Q-07301S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
A user facility reported that while using a single use preloaded sphincterotome v (distal wireguided) during a papillotomy, after 3 deliveries of current and cuts, the cutting wire broke/tore off the papillotome.The patient experienced a perforation and bled.It was stated that there was possible scarring, with a concern regarding adhesions at a later date.Nothing remained in the patient.Additional information has been requested regarding interventions and the outcome multiple times, but has not been received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the cutting wire was confirmed to be broken.The broken portion was scorched and melted.There were no other device abnormalities observed.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, although the root cause could not be identified, the broken knife wire was likely caused by the following mechanism: 1.The device did not protrude 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 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.Furthermore, although there was report of a patient hemorrhage related to this event, 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 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.¿ this supplemental report includes information added to h4.Also, an update has been made to h3.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: 16539630
• Report Number: 9614641-2023-00375
• Device Sequence Number: 7212129
• Product Code: KNS
• UDI-Device Identifier: 04953170399404
• UDI-Public: 04953170399404
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-VC611Q-07301S
• Device Lot Number: 27V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown