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

Model Number	KD-V431M-0720
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the knife wire of the single use 3-lumen sphincterotome v was turned to the 1 o'clock direction instead of the 11 o'clock direction.This occurred during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) and endoscopic sphincterotomy (est) procedure.The procedure was completed using another device and there was no report of patient harm.The device was returned, evaluated, and it was found that the cover was peeled, leaving the wire exposed.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
E1) establishment name: (b)(6) hospital.The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition to the peeled, exposed wire found, there was also a tube deformity.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Although it was determined that the knife was not oriented in the 11 o¿clock direction was due to the tube and wire deformation, a root cause of the tube and wire deformation could not be determined.After checking the instruction manual of this product, the following description was found: when inserting or removing this product from the endoscope, pull the slider slightly to advance or retract the knife wire along the curvature of the tube.If the forceps base of the endoscope is advanced or retracted while the knife wire is bent, the metal part of the forceps base may come into contact with the knife wire, possibly shaving the coating.Do not bend the tip of this product too much or deform it forcibly.Doing so may result in damage to the product.Do not insert this product into an endoscope with the knife wire taut.The knife wire may protrude sharply from the tip of the endoscope, which may lead to perforation, severe bleeding, or damage to the mucous membrane, or damage to the endoscope or this product.When inserting this product into the endoscope, hold the slider so that it does not move.If the slider is not held, the tip of the insertion part may bend and protrude sharply from the tip of the endoscope, which may lead to perforation, severe bleeding, mucous membrane damage, etc., or may result in damage to the endoscope or this product.If insertion is difficult due to high resistance, return the endoscope angle or forceps stand to a point where it can be inserted without force.Forced insertion may result in sudden protrusion from the endoscope tip, which may lead to perforation, severe bleeding, mucous membrane damage, etc., or damage to the endoscope or this product.Do not protrude the endoscope abruptly.Doing so may result in perforation, major bleeding, mucous membrane damage, or damage to the endoscope or this product.Do not insert the product by tilting it against the forceps plug of the endoscope or by holding it away from the forceps plug.Doing so may result in damage to the insertion part.Insert this product slowly.Sudden insertion may result in damage to the endoscope or this product.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: 17247278
• Report Number: 9614641-2023-00930
• Device Sequence Number: 4834145
• Product Code: KNS
• UDI-Device Identifier: 04953170380631
• UDI-Public: 04953170380631
• 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): 07/03/2023

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-V431M-0720
• Device Lot Number: 2ZV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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