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

Model Number KD-V411M-0725

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

The device with model kd-v411q-0725 returned for evaluation.The lot number was 24k with supplementary information number of ¿08¿.(m-bc manufacture date: april 8, 2022) inspection of the device found 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 cutting wire and the coated portion was measured.The distal side of the coated portion was missing approximately 2mm.Other abnormalities that could lead to the breakage of the cutting wire not observed.Review of the device history records (dhr¿s) found no abnormalities in the following record of the items below which relate to the reported phenomenon.Process inspection sheet.Quality inspection sheet.Nonconforming product report.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Instructions for use (ifu): this instruction manual (drawing no.Gk6224, revision no.9) contains the following information.Therefore, it would be possible to prevent this event from occurring.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 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 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 (description).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.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, the tear of the coated portion of the cutting wire can be replicated by the following mechanism: raise the forceps elevator of the endoscope.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.The cutting wire was moved back and forth under the circumstances described above (description #2), causing the coated portion to tear.It is possible that the slider was slightly pushed hard.This possibly caused the cutting wire to deflect.It can be inferred that some kind of force might have applied to the coated portion of the cutting wire when the device was withdrawn from the papilla of vater and/or endoscope after the coated portion of the cutting wire has torn.This might have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.However, the exact cause could not be identified.Olympus will continue to monitor complaints for this device.

Event Description

As reported, the doctor used the kd-v411m-0725 during the therapeutic duodenal papillotomy (est) procedure to make a small to medium incision on the nipple, and the knife wire broke while the electricity was being applied.Part of the broken pieces fell out into the body.The broken pieces could not be recovered.The doctor replaced the device with another of the same model and completed the procedure.No patient health hazard.According to the reporter as per the doctors opinion, although the fallen pieces could not be collected, it was determined that there would be no problem with natural discharge.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to inform a correction in h10 from the initial report.The model number is being corrected from kd-v411q-0725 to kd-v411m-0725.The model was a typo error and the correct model is kd-v411m-0725.The letter q is a typo, it should be letter m.The model from the initial mdr report in section d4 (kd-v411m-0725 ) is correct.

• 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, 036-0357 ; JA
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15514563
• MDR Text Key: 300879786
• Report Number: 9614641-2022-00390
• 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,Followup
• Report Date: 10/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0725
• Device Lot Number: 24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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