MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0730

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 07/28/2022

Event Type  Injury  

Event Description

The customer reported to olympus, during a papillotomy, the cutting wire was missing after the cutting and coagulation current was released.A remnant of the cutting wire was still visible.The physician suspects the bleeding was probably caused by the instrument when it was pulled back out of the bile duct system/ the bleeding could be stopped with a stent placement/plastic drain and injection of adrenaline.The patient is currently reported as doing "good" and has not had further complications.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the user facility.See b5 for more detailed information.

Event Description

It was further reported that patient¿s current condition is good, and no other complications reported.The intended procedure was successfully completed, and the patient received a plastic drain after hemostasis with injection was performed.The cutting wire was found in the papillotome.The sphincterotome was discarded following the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the breakage of the cutting wire occurred during the following situations: 1.High frequency current was conducted between the cutting wire and the tissue at the point of contact, or high frequency current was conducted when they were being close to each other.An electrical discharge might have occurred.This might have caused the cutting wire to become hot instantly.As a result, the cutting wire broke.2.Hight frequency current was conducted between the cutting wire and the distal end of the endoscope at the point of contact, or high frequency current was conducted when they are being close to each other.An electrical discharge might have occurred.This might have caused the cutting wire to become hot instantly.As a result, the cutting wire broke.3.Output was activated in the ¿coagulation¿ mode.This might have caused the cutting wire to burn out.Furthermore, when the device was withdrawn from duodenal papilla, it is likely that the broken portion of the cutting wire came into contact with the tissue.This may have caused the tissue damage and bleed.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument 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.¿ ¿do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together.This could burn the tissue and/or damage the endoscope or the instrument.¿ ¿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 of the instrument.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15316472
• MDR Text Key: 298871171
• Report Number: 9614641-2022-00228
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170380594
• UDI-Public: 04953170380594
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0730
• Device Lot Number: 25V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention