MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, MONOPOLAR, SINGLE-USE

Model Number KD-V411M-0320

Device Problem Break (1069)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

It was reported the device failed and did not work accordingly.Reporter stated no patient was injured.According to the reporter, the customer was able to complete the procedure using another unit.There was no patient harm, no user injury reported due to the event.Device evaluation found broken cutting wire, melted at the broken ends, with charred stains on wire indicating thermal damage.

Manufacturer Narrative

The subject device was received and evaluated.The device evaluation results and legal manufacturer investigations were noted below: the lot number was 1yv with supplementary information number of ¿05¿.(m-bc manufacture date: november 05, 2021) visual inspection as received condition found cutting wire broke, melted at broken ends, and has charred stains on wire indicating of thermal damage.No missing fragment noted on the cutting wire, and the blue coated portion is still present, but slightly melted.The broken wires were measured on each side, about 12mm from the distal and 8mm from proximal markers.In addition, found no biomaterial inside the tube sheath and its working section has no visual damage.The handle section is operational as it could extend or retract the broken cutting wire at the proximal green marker without a problem.There is continuity between the plug contact pin and the proximal broken wire, but due to the damaged cutting wire, the device could not be checked for energy output.The device history record for the lot indicated no anomaly with the event-related items.The record includes the following: process inspection sheet, quality inspection sheet, nonconforming product report.This instruction manual contains the following information.(drawing no.Gk6226 revision no.13).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.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.Based on the results of confirmation of the device and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.1.The device was not protruded 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 being 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.It can be inferred that heat generated by an electrical discharge caused damage (melted) of the coated portion.Olympus will continue to monitor complaints for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.¿ supplemental report(s) will be submitted should any relevant new information is available.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, MONOPOLAR, SINGLE-USE
• 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: 14692467
• MDR Text Key: 302355582
• Report Number: 8010047-2022-10056
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382604
• UDI-Public: 04953170382604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0320
• Device Lot Number: 1YV 05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1