MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V

Model Number	KD-V631M-07201S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.
Event or Problem Description
A user facility reported to olympus that the wire broke during a procedure.There was no patient injury, associated with the problem, reported to olympus.This is report #2 of 2 due to multiple events reported.
Event or Problem Description
Added patient identifier (b)(6) to account for referenced multiplicity of complaints reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.B5: added related patient identifier.The subject device was not returned to olympus.The device history records below were reviewed for the lots 14v through 23v* since the lot number of the device and the event occur date was unknown.The review revealed the lots had passed all the inspections relating to the reported incident.Process inspection sheet, quality inspection sheet, nonconforming product report.*these lots were manufactured one year before the event date.Based on the similar complaint investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.·high frequency current was applied between the cutting wire and the tissue at the point of the contact.As a result, the current density at the contact area increased, and the cutting wire became instantly hot.·high frequency current was applied when the cutting wire and the tissue were being close to each other.As a result, an electrical discharge occurred, and the cutting wire became instantly hot.·high frequency current was applied when the distal end of the device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.The cutting wire and the tissue were being close to each other.As a result, an electrical discharge between the cutting wire and the distal end of the endoscope occurred, and the cutting wire became instantly hot.The event can be prevented by following the instructions for use which state: ¿ do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.¿ do not stretch the cutting wire too tightly.This could damage the sphincterotome.¿ 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.¿ be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.Insufficient output or unintended tissue injury may occur in case the cutting wire contacts the forceps elevator.¿ aspirate fluids such as mucus and contrast medium that adhere to the cutting wire, tube, and body cavity tissues.Patient injury such as perforations, bleeding, mucous membrane damage, and thermal injury of tissue could result if output is activated with these fluids adhering.¿ always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforations, bleeding, or mucous membrane damage.¿ when applying the current, do not use an excessive/insufficient amount of conduction.Doing so could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.¿ when activating output, set the output mode of the electrosurgical unit to ¿cut¿ or ¿blend¿.Activating output in the ¿coagulation¿ mode could break the cutting wire.¿ do not use this sphincterotome and a cord with an output higher than the rated high-frequency voltage given in the tables in section 9.2, ¿specifications¿.This could cause thermal injury to the patient, operator, or assistant and could also damage the endoscope, instrument, and/or a cord.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V
• Common Device Name: SINGLE USE PRELOADED 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: 14287993
• Report Number: 8010047-2022-07608
• Device Sequence Number: 17494668
• Product Code: KNS
• UDI-Device Identifier: 04953170403163
• UDI-Public: 04953170403163
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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-V631M-07201S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown