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

Model Number KD-V411M-0320

Device Problem Break (1069)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.We have verified the actual product.The product model was kd-v411m-0320, and not kd-v451m as previously reported by the customer, with lot number 22k and supplemental information "18" (manufactured on february 18, 2022).Device evaluation, the following were noted: the cutting wire was broken.The broken portion was scorched and melted.The length of the knife wire and wire sheath was confirmed to be fine, with no fluffing or missing parts.No other abnormalities were confirmed except the breakage of the cutting wire.The dhrs (device history records) for this product have been reviewed.No abnormalities were 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 (drawing no.Gk6224, revision no.7) 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 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.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.Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other.3.The output was activated in state of ¿2¿ description.This might 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.Olympus will continue to monitor complaints for this device.

Event Description

Customer reported that during pre use inspection/ preparation for use and when operated the device with model kd-v451m, it was observed that the knife could not protrude.The device was replaced with another similar device and the intended procedure was completed with no patient harm or injury reported.There was no user injury reported due to the event.Device return evaluation found the knife wire of the device model kd-v411m-0320 (not the model kd-v451m customer previously reported) was broken and the broken part was found charred and melted.This report is being submitted for broken knife wire found on device evaluation.

Manufacturer Narrative

Updated d4, please see d4 for further information.

• 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: 15271903
• MDR Text Key: 305537037
• Report Number: 9614641-2022-00177
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170183973
• UDI-Public: 04953170183973
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0320
• Device Lot Number: 22K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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