MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0320
Medical Device Problem Codes	Break (1069); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned to olympus for evaluation.Inspection and testing confirmed the reported event.The cutting wire (knife wire) was confirmed to be broken and the broken portion was scorched and melted.The coating of the cutting wire was torn.When the outer diameter of the cutting wire was measured, there was no abnormality identified.It was also confirmed that there were no abnormalities with the length of the cutting wire and wire itself.There were no missing parts in the device and no defects were identified with the device that could have caused the breakage of the cutting wire.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely the cutting wire broke due to the cutting wire at the torn area of the coated portion coming into contact with the distal end of the endoscope while the forceps elevator was raised.The output was then activated with the cutting wire in contact with the endoscope, causing the cutting wire to become instantly hot, resulting in the broken wire.In addition, based on the results of the legal manufacturer's investigation, it is likely the coated portion of the cutting wire had a tear due to the forceps elevator of the endoscope being raised, and the slider was pushed more than needed, causing the cutting wire to deflect.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.The cutting wire was moved back and forth, causing the coated portion of the cutting wire to tear.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warnings which may help to prevent the reported 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." "if you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion." olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported the knife wire of the sphincterotome broke during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) when the high frequency was output.The procedure was completed with a new device of the same model.There was no impact on the patient.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated field: h6 - investigation findings: addition of codes 3243 and 4217.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13561052
• Report Number: 8010047-2022-03218
• Device Sequence Number: 11717035
• Product Code: KNS
• UDI-Device Identifier: 04953170183973
• UDI-Public: 04953170183973
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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-V411M-0320
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2021
• 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: ERBE ELECTROSURGICAL UNIT
• Patient Sex: Unknown