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

Model Number KD-V411M-0725

Device Problems Break (1069); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation. During inspection and testing, the cutting (knife) wire was confirmed to be broken. The coated portion of the cutting wire was torn, and the broken portion was scorched and melted. The coated portion had adhered to the distal side of the cutting wire and the wire had come out of the coated portion where it was torn. A review of the device history record found no deviations that could have caused or contributed to the reported issue. The length of the cutting wire, length of the coated portion, and operation of the cutting wire met 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 point where the coating was torn came into contact with the distal end of the endoscope while the forceps elevator was raised. The output was then activated, causing the cutting wire to become instantly hot, resulting in breakage of the cutting wire. Based on the results of the legal manufacturer's investigation, it is likely the coated portion was torn with the forceps elevator of the endoscope in the raised position, when the cutting wire deflected, the coated portion of the cutting wire and the metal part of the distal end of the endoscope came into contact. The cutting wire then moved back and forth, causing the coated portion of the cutting wire to tear. The slider was pushed more than needed causing the cutting wire to deflect. 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 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 Description

The customer reported the knife wire of the subject device broke when it was energized in the middle of an endoscopic sphincterotomy procedure. The intended procedure was completed with another device. There was no patient/user harm or injury reported due to the event. The user facility confirmed that energization was checked prior to usage and no issues were identified. Additional information regarding the reported event was requested from the user facility, but the information was not known.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: 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: 13780067
• MDR Text Key: 287265890
• Report Number: 8010047-2022-04495
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: KD-V411M-0725
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial