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

Model Number KD-V411M-1530

Device Problem Break (1069)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

As reported, during an est (endoscopic sphincterotomy) therapeutic procedure the knife wire of the device broke when energized.The patient was exposed during the case , the output performed , knife was activated outside the patient.The device was replaced with similar device.No health hazard has occurred.The intended procedure was completed with no harm or injury to the patient.No user injury reported.The hf (electrosurgical unit ) used and output value are unknown.Not provided.The device was inspected prior to use.

Manufacturer Narrative

The device kd-v411m-1530 was returned for evaluation.The lot number was 1zk with supplementary information number of ¿24¿.(m-bc manufacture date: december 24, 2021).Device evaluation, the following were noted: the cutting wire was broken.The coated portion of the cutting wire was torn, and the broken portion was scorched and melted.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.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.Other abnormalities that could lead to the breakage of the cutting wire were not confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Length of cutting wire.Length of coated portion.Operation of cutting wire.The instruction manual (drawing no.Gk6224, revision no.8) contains the following information.Therefore, it would be possible to prevent this event from occurring.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 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.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.However, the exact cause of the problem could not be conclusively identified.Based on the confirmation result and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.However, the exact cause of the problem could not be conclusively identified.Likely the phenomenon occurred due to the following : the cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised.The output was activated in state of ¿1¿ description, and the cutting wire became hot instantly.This caused the cutting wire to break.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The tear of the coated portion of the cutting wire was reproduced.It was thought that the tear occurred according to the following mechanism: 1.The forceps elevator of the endoscope was raised.2.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.3.As described in (2), the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.Additionally, the slider was pushed more than needed.This caused the cutting wire to deflect.Olympus will continue to monitor field performance for 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: 14413875
• MDR Text Key: 291828435
• Report Number: 8010047-2022-08343
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184093
• UDI-Public: 04953170184093
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-1530
• Device Lot Number: 1ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2021
• 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
• Treatment: VIO3 ELECTROSURGICAL UNIT.POWER SUPPLY: VIO3.
• Patient Age: 72 YR
• Patient Sex: Male