MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0720

Device Problem Break (1069)

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

Event Date 08/13/2022

Event Type  malfunction  

Manufacturer Narrative

E1- address- full name of the customer establishment is social medical corporation zenjinkai miyazaki zenjinkai hospital.The device with model no.Kd-v411m-0720 was returned for evaluation.The lot number was 22k with supplementary information number of ¿01¿.(m-bc manufacture date: february 02, 2022).Device evaluation, the following information were noted: the cutting wire was broken.Investigation carried out to confirm the broken portion.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 not confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities found 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 instruction for use (ifu): this instruction manual contains the following information.(drawing no.Gk6224 revision no.8) ¿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.Based on the result of confirmation of the device, and the result of past similar complaint investigation, a likely mechanism causing the cutting wire breakage might be the following (descriptions below).However, the exact cause could not be determined.1.The cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised.2.Under circumstances described above (description 1), an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.In addition, it has been confirmed that the tear of the coated portion of the cutting wire can be replicated by the following mechanism: 1.Raise the forceps elevator of the endoscope.2.Once the cutting wire deflects, the coated portion of the wire comes into contact with the metal part of the distal end of the endoscope.3.The cutting wire was moved back and forth under the circumstances described above (description 2), causing the coated portion to tear.Based on evaluation and investigation, it is possible that the slider was slightly pushed hard.This possibly caused the cutting wire to deflect.Olympus will continue to monitor complaints for this device.

Event Description

As reported, during a therapeutic endoscopic retrograde cholangiopancreatography procedure, the electricity was not turned on at the first output.When the doctor checked the knife wire, it was cut.The broken knife wire did not fall and the intended procedure was completed with a new knife.There was no patient harm, no user injury reported due to the event.No abnormalities were found during the pre-use inspection of the device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15422723
• MDR Text Key: 306189033
• Report Number: 9614641-2022-00311
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

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
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0720
• Device Lot Number: 22K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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