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

Model Number KD-V411M-0330

Device Problems Break (1069); Melted (1385)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.Upon inspection and testing of the device, it was confirmed that the cutting wire (knife wire) was broken.The broken portion was burnt and melted.The outer diameter of the cutting wire was measured and no abnormalities were observed.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.There were no abnormalities identified that could have led to 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 possible that an electrical discharge occurred, causing the cutting wire to become instantly hot, resulting in the breakage of the cutting wire.It is also possible that a high frequency current was conducted at the point of contact between the cutting wire and the distal end of the endoscope or if the devices were close to each other.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 that during a therapeutic endoscopic sphincterotomy (est) procedure, the knife wire broke when it was energized.Another device of the same model was used to complete the intended procedure.There was no prolongation of the procedure.There was no report of patient or user injury due to the event.

Manufacturer Narrative

Corrected fields: h6 (addition of historical data analysis) and h10.H8 - selected in error, unable to unselect.This report is being supplemented to provide a correction to the legal manufacturer's investigation.Based on the investigation result and the similar complaint investigation results in the past indicates that the cause of the breakage of the wire might be in following states.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That have caused the cutting wire to break.High frequency current was conducted between the cutting wire and the distal end of the endoscope at the point of contact or the devices being closed to each other.Olympus will continue to monitor the field performance of this device.

• 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: 14018216
• MDR Text Key: 298310067
• Report Number: 8010047-2022-05748
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382611
• UDI-Public: 04953170382611
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0330
• Device Lot Number: 18K 24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ERBE VIO200D ELECTROSURGICAL UNIT.