MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, reported issue was confirmed.In addition, the wire coating was torn and the broken part was burnt/melted.The outer diameter of the knife wire was measured and there was no abnormality.However, when the length of the knife wire and the wire coating was measured and the wire coating was missing 3.5 to 5.5 mm from the tip side.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the single use 3-lumen sphincterotome v knife broke at the tip.The event occurred during a diagnostic endoscopic retrograde cholangiopancreatography procedure.The operation was completed by replacing the product and there was no patient harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation results, the event was likely caused by external force being applied to the coated portion of the cutting wire when the device was withdrawn from the endoscope after the coated portion of the cutting wire was torn.This might have caused the coated portion of the cutting wire to detach from the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 definitive root cause of the reported event could not be determined.The following mechanisms should be avoided to prevent the cutting wire from breaking: 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.The following mechanisms should be avoided to prevent the tear of the coated portion of the cutting wire: 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.4.The slider was pushed more than needed.This caused the cutting wire to deflect.This instruction manual contains the following information: "-since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the cutting 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 cutting 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 device 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 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN 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: 14350361
• MDR Text Key: 299932925
• Report Number: 8010047-2022-08024
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170380556
• UDI-Public: 04953170380556
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 1ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2021
• 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