MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)

Model Number	KD-VC631Q-07201S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received at olympus service business center, however, pending device evaluation.The evaluation has not yet started.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure when the doctor decided to cut the ampulla (sphincterotomy), the cutting wire broke suddenly when pushed on the paddle of the electrocautery.The doctor was not able to cut the ampulla.No injuries to the patient.Nothing left in the patient (wire), confirm by x-ray.The doctor changed that tome and take another one from boston scientific (jagtome).The intended procedure was completed using a similar device.Slight delay (unspecific delay) was reported, however, no impact to the patient, no harm was reported, no patient injury, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's final investigation.Investigation result.The subject device was returned to service business center olympus (sbc).The evaluation results by sbc were below.Kd-vc631q-07201s was received, device actual lot# 29v 27.The cutting wire on the distal end is broken and damaged.The distal end was examined under a microscope and identified char marks on the damage cutting wire.There is a portion missing of the cutting wire, which was not returned for evaluation.A piece of the coated insulation is still intact with a portion of the cutting wire however it appears a portion of the coated insulation is missing as the edges of the remaining coated portion has jagged edges.Performed inspection over the entire length of the insertion portion and verified there were no excessive bends, kinks or cuts.There was some discoloration observed inside the tubing of the device.The handle and injection port have no signs of cracks or damages.Functional testing was unable to be performed, as the cutting wire was damaged and broken.The subject device was manufactured on september 27, 2022.The device history record (dhr) with the lot number of the subject device was confirmed.No abnormalities detected in the dhr for the following items, which related to the reported phenomenon.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The device history record found the subject device was shipped in accordance with specifications.This instruction manual contains the following information.(drawing no.Gk9051 revision no.10).The device's instruction manual provides the following warnings, which may help to prevent the issue: 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.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.Based on the confirmation result and similar complaint investigation results in the past, a likely cause of the cutting wire breakage might be the following reasons.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.However, the exact cause of the problem could not be conclusively identified.It can be inferred that some kind of force might have applied to the broken cutting wire when the device was withdrawn from endoscope after the cutting wire has broken.This might have caused the cutting wire to detach from the device.However, the exact cause of the reported event could not be identified.Olympus will continue to monitor complaints for this device.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16561576
• Report Number: 9614641-2023-00388
• Device Sequence Number: 5691411
• Product Code: KNS
• UDI-Device Identifier: 04953170399466
• UDI-Public: 04953170399466
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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-VC631Q-07201S
• Device Lot Number: 29V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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: ELECTROCAUTERYUNKNOWN MODEL
• Patient Sex: Unknown