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 02/20/2022

Event Type  malfunction  

Event Description

The device was returned by the customer for the issue of the knife wire of the device being in the wrong direction when removed from the sterile packaging during preparation for use.The device was not used in the procedure and the intended procedure was completed with a new device.Upon evaluation of the returned device, it was observed that the knife wire was broken on the wire coating.The wire coating was torn and the broken part was scorched and melted, indicating that the device was activated.This medwatch is being submitted for the reportable issue of the broken knife and broken part being scorched and melted as observed during device evaluation.Addendum mar 9, 2022: customer provided additional information that pre-inspection was not performed before inserting the device to the endoscope.The breakage of the cutting wire was found during an attempt of activation.It is unknown whether the output of the device was activated once.

Manufacturer Narrative

The device is returned and an evaluation completed for it.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 at inspection for: length of cutting wire.Length of coated portion.Operation of cutting wire.Direction of cutting wire.Upon inspection and testing, it was observed that the knife wire was broken on the wire coating.The wire coating was torn and the broken part was scorched and melted.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.Exact cause of the issue cannot be determined.It is likely the cause is as below: ¦breakage of the cutting wire based on the confirmation result and the investigation results in the past, a likely cause of the cutting wire breakage might be the following.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 that state, and the cutting wire became hot instantly.This caused the cutting wire to break.It has been confirmed that the tearing of the coated portion of the cutting wire can happen as follows: 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 that state, 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.This caused the cutting wire to deflect.¦poor orientation of the cutting wire since the cutting wire was broken, the poor orientation of the cutting wire could not be confirmed.The distal end of the tube was deformed.Therefore, it can be inferred that the poor orientation of the cutting wire occurred by the deformation of the tube.The shape of the distal end of the product undergo 100% inspection.Therefore, it is possible that a force was applied to the distal end of the product during device handling as described below.This might have caused the tube to deform: when pre-curved stylet was removed.When an attempt was made to curve the distal end of the tube.When the device was inserted into the endoscope.When an attempt was made to extend the distal end of the tube while the forceps elevator was raised.When the guide wire was inserted into the distal end of the tube, if the guide wire was used for the procedure.This instruction manual contains the following information regarding the event: 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.Do not use excessive force to bend the distal end of the instrument.This could damage the cutting wire and/or the instrument.When inserting the instrument into the endoscope, hold the slider firmly.Otherwise, the distal end of the insertion portion may angle and extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.When inserting the instrument into the endoscope, hold the slider firmly.Otherwise, the distal end of the insertion portion may angle and extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator until the instrument passes smoothly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the endoscope and/or instrument.Do not advance or extend the instrument abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the endoscope and/or instrument.When inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.

Manufacturer Narrative

Corrected field: correction to g3 of the initial medwatch (mfr# 8010047 2022 04675).The aware date should be 21-feb-2022.Updated fields: d8 and h6 (investigation findings).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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: 13826868
• MDR Text Key: 297221126
• Report Number: 8010047-2022-04675
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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 Model Number: KD-V411M-0320
• Device Lot Number: 19K 07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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
• Treatment: SCOPE