MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD SINGLE USE PRELOADED SPHINCTEROTOME V

Model Number KD-V611M-07251S

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

As stated in b5, the two device reported with the same phenomenon were disposed by the customer and not returned for evaluation.However; olympus opened complaints to document the two reported failure under complaints (b)(6).Device evaluation of the returned device (3rd device) and investigation result of the reported event: device return: the model no.Was kd-v611m-07251s.The lot number was 11v with supplementary information number of 12.(m-bc manufacture date: jan 12, 2021).The cutting wire was broken.Investigation was 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 coated portion was torn at approximately 3.0mm from the broken portion.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 were not confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected 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.Ifu (instruction for use): this instruction manual (drawing no.Gk8464 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 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.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 investigation result and similar complaint investigation results in the past indicates that the cause of the cutting wire breakage might be the following reasons.However, the exact cause of the problem could not be conclusively identified.The cutting wire was out of a torn area of the coated portion while the forceps elevator of the endoscope was being up.As a result, the cutting wire had contact with the distal end of the endoscope.In the state of being ¿1¿, the electric conduction was activated.The temperature of the cutting wire instantly became very high at the contact point.This caused the cutting wire to break.It has been confirmed that the tear of the coated portion of the cutting wire could duplicate by the following mechanism.The forceps elevator of the endoscope was being up.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope had contact with each other.In the state of being¿2¿, the cutting wire moved back and forth.This caused the coated portion of the cutting wire to tear.The slider was pushed more than needed.This caused the cutting wire to deflect.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.Olympus will continue to monitor complaints for this device.

Event Description

As reported, within a short time, the wire broke on three papilotomes device (kd-v611m-07251s, batch lot 11v).According to the customer without much effort on the handpiece, there is no injury to the patient.According to the report, for the first two device, the customer did not contacted olympus and disposed the defective device.The other defective device (third device) was kept and returned to olympus for evaluation.There was no patient harm, no user injury reported due to the event.Evaluation of the returned device found the cutting wire was torn, broken and noted melted and scorched.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki- 1; 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: 15080650
• MDR Text Key: 301997010
• Report Number: 9614641-2022-00023
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170403088
• UDI-Public: 04953170403088
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V611M-07251S
• Device Lot Number: 11V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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