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 Problem Break (1069)

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

Event Date 09/08/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, during a therapeutic duodenal papillotomy (est) procedure the doctor issued the second output, the device knife wire broke.The procedure was completed with a new similar device.There is no harm or adverse impact to the patient.

Manufacturer Narrative

The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Upon inspection of the device, it was observed that the knife wire was broken.The broken part was charred black and melted.In the investigations conducted in the past, the damage to the wire coating was reproduced by the heat generated when an electrical discharge occurred; the shape of the wire coating on the actual device was similar to the shape of the wire coating in the simulation study.When measured, there was no abnormality in the outer diameter of the knife wire.It was confirmed that there were no problems with the length of the knife wire and wire coating, and that there were no defects in the actual product.Due diligence was performed to collect more information on the event that could lead to understanding of the root cause.However, no response was received.No other abnormalities that could lead to breakage of the knife wire could be confirmed.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.Therefore, the cutting wire and the endoscope were brought close to each other.3.When output was activated in this situation, it may 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 of the coated portion.This instruction manual contains the following information, which can 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 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.

• 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: 15535914
• MDR Text Key: 306696367
• Report Number: 9614641-2022-00403
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170380587
• UDI-Public: 04953170380587
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• 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: 25K 12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• 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