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 08/10/2022

Event Type  malfunction  

Event Description

The customer reported that during a therapeutic endoscopic sphincterotomy (est) procedure, the tip of the knife wire broke.Reportedly, no fragments fell off.Another similar device was used to complete the intended procedure.There was no patient or user injury reported due to the event.

Manufacturer Narrative

The suspect device is expected to be returned to olympus for further evaluation and testing.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where the lot number was confirmed (see d4), the knife wire had broken, the broken part was charred black and melted, and the cutting wire was broken.In past investigations, the damage to the wire coating was reproduced by the heat generated when the discharge occurred, and the shape of the actual wire coating was similar to the shape of the wire coating in the simulation study.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.In addition, no abnormalities leading to breakage of the knife wire could be confirmed.Other abnormalities that could lead to the breakage of the cutting wire were not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, 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 did not protrude from the endoscope until the trailing edge of the knife wire was in the field of view.2) due to 1), the knife wire was close to the tip of the endoscope.3) electric discharge occurred between the knife wire and the tip of the endoscope because the current was applied in the state of 2).It is likely the damage to the wire coating was caused by the heat generated when the discharge occurred.It can be inferred that heat generated by an electrical discharge caused damage of the coated portion.The following is included in the instructions for use (ifu): "·since the knife wire must be very thin, it can be used if the length of contact with the duodenal papilla is short, if the high-frequency output is high, if the wire is energized while in contact with the metal part of the endoscope, or if the wire is stretched too tightly.May cut the knife wire.When the knife wire is cut, if force is applied in the direction of tensioning the knife wire, the proximal part of the cut knife wire will be pulled in the direction of the endoscope, and force will be applied in the direction of pushing the knife wire.If you have it, it will be pushed out in the direction of the nipple or bounce sideways.If the knife wire is cut, immediately stop the power supply, pull the slider on the operating part completely, draw the cut knife wire into the tube, and then quickly remove the product from the nipple.A broken knife wire can lead to perforation, hemorrhage, bile duct laceration, and damage to the endoscope.When energizing, make sure that the rear end of the knife wire is within the field of view of the endoscope.If power is applied while the forceps base and knife wire are in contact, current leakage may occur, resulting in reduced output or unintended tissue burns.Do not turn on the power while the metal tip of the endoscope and the knife wire are in contact or close to each other.It may lead to tissue burns, etc., and may lead to damage to the endoscope or this product.This instruction manual (drawing no.(b)(4), revision no.9) contains the following information.Therefore, it would be possible to prevent this event from occurring." 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): 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: 15438588
• MDR Text Key: 306424489
• Report Number: 9614641-2022-00330
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184017
• UDI-Public: 04953170184017
• 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: 11/03/2022

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: 25K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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