MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0725

Device Problem Break (1069)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The subject device was returned for evaluation.Device evaluation, the following findings and investigation were noted : the part of the insulation coating on the distal end of the device was scratched and peeled off, exposing the knife wire.The knife wire was fused in the insulation coating part.The cutting wire was broken near the proximal side.The broken portion of the cutting wire scorched and melted.The coated portion of the cutting wire was torn.The subject device was manufactured on september, 2021 based on the provided 3 digit lot information.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.This instruction manual contains the following information.(drawing no.Gk6226 revision no.13) 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.Conclusion summary: since the broken portion of the cutting wire was scorched and melted, it can be inferred that the cutting wire was broken while the output was activated.Based on the confirmation result by s-bc ( service business center), and the result of past similar complaint investigation, a likely mechanism causing the cutting wire breakage might be the following.However, the exact cause could not be determined.The cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised.Under circumstances described above 1, an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.In addition, it is confirmed that the tear of the coated portion of the cutting wire can replicate by the following mechanism: raise the forceps elevator of the endoscope.Once the cutting wire deflects, the coated portion of the wire comes into contact with the metal part of the distal end of the endoscope.The cutting wire was moved back and forth under the circumstances described above 2, causing the coated portion to tear.It is possible that the slider was slightly pushed hard.This possibly caused the cutting wire to deflect.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that during a choledocholithiasis ercp procedure, it was found that the knife wire was broken.The user changed to another one and the intended procedure was completed.There was no patient harm or injury reported due to the event.No user injury reported.

• 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: 14403445
• MDR Text Key: 291742040
• Report Number: 8010047-2022-08267
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184031
• UDI-Public: 04953170184031
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0725
• Device Lot Number: 19K
• 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: 04/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: TJF-260V SCOPE
• Patient Age: 73 YR
• Patient Sex: Male