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

Model Number	KD-V431M-0730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center confirmed the reported event; the cutting wire was bent where it broke off at the proximal green marker and the knife length sticking out measured 25mm.No missing fragments.The coated portion covering the knife was missing and charred stain on the cutting knife due to thermal damage.The remaining wired passed the continuity inspection when checked with its active plug pin.The handle is functional and could extend and retract the remaining cutting wire inside the sheath smoothly.The ports and plug contact pin are intact.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus the subject device cutting wire broke during an unknown procedure.The subject device was being used with a fuji endoscope and an erbe generator.The cutting wire appeared burnt where it broke and the catheter dislodged from the catheter.A non-olympus sphincterotome was used to complete the procedure.The customer reported no patient injury or harm.No additional information was provided.
Additional 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 investigation results, 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.It is likely some kind of force might have applied to the coated portion of the cutting wire when the device was withdrawn from endoscope.This might have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.However, the exact cause of the reported event could not be identified.The following information is stated in the instructions for use which may have prevented the event: 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.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional investigation results.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the torn coating could not be determined, likely factors causing the tear could have been the following: - the knife wire was deformed and the coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.- it is possible that the slider was slightly pushed causing the cutting wire to deflect.The coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.Although a definitive root cause of the damaged knife wire could not be determined, 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 and melt.- 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 between the cutting wire and the tissue, and the cutting wire became instantly hot and melt.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : - 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.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; 2-248-1 okkonoki, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13283117
• Report Number: 8010047-2022-01572
• Device Sequence Number: 4944692
• Product Code: KNS
• UDI-Device Identifier: 04953170184192
• UDI-Public: 04953170184192
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K950166
• 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,Followup,Followup
• Report Date (Section B): 05/06/2024

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-V431M-0730
• Device Lot Number: 14V17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 03/28/2022; 01/12/2024; 05/06/2024
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 04/26/2022; 01/22/2024; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2021
• 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: FUJI ENDOSCOPE AND AN ERBE GENERATOR.
• Patient Sex: Unknown