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 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Communication with the customer , the following information was provided: the knife broke when press the foot switch of the electrosurgical unit to activate output and perform the incision.Setting value of the cut mode (35w and coagulation 40w).Broken knife wire broke and did not fall into patient body.Reported event occurred about 30 minutes after the procedure started.Reporter stated seeing from the scope the wire was contacting the tissue directly.The subject device was received and evaluated.Device inspection and evaluation, the following information noted : the lot number was 19k with supplementary information number of ¿27¿.(m-bc manufacture date: september 27, 2021) device evaluation noted the cutting wire was found fused in the insulation coating part.Cause: the blue mark of the knife wire in the endoscopic field of vision is the best cutting position, and it is recommended to use the best cutting position.The cutting wire near the coating position is too blunt during cutting.If the adjusted output value is too high, the cutting wire may be broken.In addition, breakage near the insulating coating may be caused by starting the output when the cutting wire is in contact with the metal parts of the endoscope.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.Instruction for use (ifu) : 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.Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.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 results of confirmation of the device and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.1.The device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.2.Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other.3.The output was activated in state of ¿2¿ description.This might have led to an electrical discharge between the cutting wire and the distal end of the endoscope.4.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That might have caused the cutting wire to break.Olympus will continue to monitor complaints for this device.

Event Description

As reported, during the ercp (endoscopic retrograde cholangiopancreatography) procedure, knife of subject device broke inside patient but was retrieved.No injury reported.The intended procedure was completed with another device and there were no more than fifteen (15) minutes delay in the procedure.There was no patient harm or injury reported due to the event.No user injury reported.The customer returned 4 devices with the same failure description and the event date are the same for the 4 devices that reported to fail during the procedure.The lot number are the same for the 4 returned devices.This report is related to reports with patient identifier (b)(6).

• 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: 14683176
• MDR Text Key: 302162747
• Report Number: 8010047-2022-09974
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• 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(KJLOX)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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: TJF-260V SCOPEERBE VIO100C GENERATOR