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

Model Number	KD-V411M-3030
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the knife of the single use 3-lumen sphincterotome was turned in the opposite direction.The issue occurred during a therapeutic endoscopic sphincterotomy (est) procedure.Another device was used to complete the procedure.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the coating was torn.The report is being submitted due to the defect found during evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the knife was not facing the 11 o'clock direction when inserted into a scope and the knife wire was deformed.The tip of the tube was deformed and the precurve was not attached.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 issue could have been the following: 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.The cutting wire not facing the desired direction was likely due to deformation of the tube and cutting wire; however, a definitive root cause could not be determined.It's possible that a force was applied to the distal end of the product during device handling as described below.This might have caused the tube and the cutting wire to deform.When pre-curved stylet was removed.When an attempt was made to curve the distal end of the tube.When the device was inserted into the endoscope.When an attempt was made to extend the distal end of the tube while the forceps.Elevator was raised.When the guide wire was inserted into the distal end of the tube, if the guide wire was used for the procedure.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.Do not insert the instrument into the endoscope when the cutting wire is tightened.Doing so may extend the distal end of the insertion portion from the endoscope tip abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.When inserting the instrument into the endoscope, hold the slider firmly.Otherwise, the distal end of the insertion portion may bend and could extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope or instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly.The use of excessive force could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.Do not advance or extend the instrument abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.When inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.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 additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• 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; kuroishi-shi, 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18593965
• Report Number: 9614641-2024-00199
• Device Sequence Number: 15134946
• Product Code: KNS
• UDI-Device Identifier: 04953170184154
• UDI-Public: 04953170184154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

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-V411M-3030
• Device Lot Number: 25K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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
• Patient Sex: Unknown