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

Model Number	KD-V411M-0320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.Device inspection found the surface of the knife wire (cutting wire) was oxidized and the distal end was fused.The working handle was damaged.There was fluid accumulation in the sheath.Additionally, device evaluation/ investigation noted the following observation : accumulation of the fluid found in the sheath and surface of the knife was oxidized showed the device was used.Judging from the fusing part of the knife wire, it is likely the knife wire touch the metal of the forceps elevator when passing through the forceps elevator.Feedback : keep the knife wire in line with the insertion tube and lift the forceps elevator to the maximum height.Otherwise, the metal parts of the forceps elevator may contact the knife wire and cause the insulation coating to fall off.Do not enable high-frequency output when inserting the instrument.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.Ifu (instruction for use) : the instruction manual (drawing no.Gk6224, revision no.8) 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.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 similar complaint investigation results in the past, a likely mechanism causing the detachment of the cutting wire might be the following.1) the cutting wire was being close to the tissue or endoscope.2) the output was activated , the cutting wire was being close to the tissue or endoscope.3) during activation, accidental discharge might have occurred at two points in the cutting wire at the same time.4) the discharge caused the cutting wire to become hot instantly.As a result, the cutting wire was broken and detached.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that during est (endoscopic sphincterotomy) ercp (endoscopic retrograde cholangiopancreatography) procedure, the cutting wire broke inside the patient and was retrieved.The intended procedure was completed with a similar device.There was no patient harm or injury reported due to the event.No user injury reported.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: 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: 14078501
• Report Number: 8010047-2022-06080
• Device Sequence Number: 5251535
• Product Code: KNS
• UDI-Device Identifier: 04953170183973
• UDI-Public: 04953170183973
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: KD-V411M-0320
• Device Lot Number: 18K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-260V (SCOPE)
• Patient Sex: Unknown