MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number KD-VC611Q-07301S

Device Problems Break (1069); Melted (1385); Material Split, Cut or Torn (4008)

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

Event Date 01/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to olympus for evaluation; however, the device has not been received.The investigation is ongoing; therefore, a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The pharmacist at the user facility reported that the cutting wire of the sphincterotome broke during a procedure.The procedure was completed using a similar device.There was no patient harm or user injury reported due to the event.Three attempts were performed to obtain additional information, but no response was received from the customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the evaluation of the returned device and the legal manufacturer's final investigation.During inspection and testing of the returned device, it was confirmed the cutting (knife) wire was broken.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 and no abnormalities were observed.The length of the cutting wire and the coated portion were measured.The distal side of the coated portion was missing approximately 15.0-17.0 mm.The piece of missing coating was not returned to olympus.Multiple documented attempts to obtain additional information were performed, but no response was received from the customer.Therefore, it is unknown what happened to the missing piece of coating.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, a likely mechanism causing the broken cutting wire may be the following.However, the exact cause of the problem could not be conclusively determined.1.The cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised.2.The output was activated in state of ¿1¿ description, and the cutting wire became hot instantly.This caused the cutting wire to break.It has been confirmed that the tear of the coated portion of the cutting wire could have occurred by the following mechanism.1.The forceps elevator of the endoscope was raised.2.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.3.In state of description ¿2¿, the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.The slider was pushed more than needed, which caused the cutting wire to deflect.It can be inferred that some kind of force may have been applied to the coated portion of the cutting wire, when the device was withdrawn from the endoscope, after the coated portion of the cutting wire was torn.This may 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 of the reported event could not determined.Avoiding the above situations will prevent the cutting wire from breaking.The device's instruction manual provides the following warnings regarding the prevention of the reported issue: " 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 cutting wire touches metal parts of the endoscope, or the cutting wire is 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 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 sphincterotome from the scope to examine if there is any peel off and tear at the coating portion." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13742788
• MDR Text Key: 296870937
• Report Number: 8010047-2022-04335
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170399404
• UDI-Public: 04953170399404
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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-VC611Q-07301S
• Device Lot Number: 1804V/14V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/12/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• 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