MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number	KD-V451M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full e1 establishment name:(b)(6) hospital.During device evaluation at olympus, it was found the dissection knife pierced the tube approximately 5 mm from the tip of the tube and the wire sheathing was curled up.The knife was deformed, there was foreign matter attached to the needle, and the wire coating was rolled up.During device evaluation at olympus, it was found the insertion part was broken and the grip part had fallen off.There was no damage to the broken insertion part and the pad was not peeled.The grip was scratched and the coating of the grip was peeled off.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, it's likely the cutting knife was moved while the end face of the coated portion of the wire was caught on inner wall of the tube.Although a definitive root cause of the broken distal end could not be determined, likely factors causing the issue could have been the following: 1 - the cutting knife was advanced or retracted with the forceps table of the endoscope in an excessively raised position.2 - the cutting knife was further deformed due to the bending load applied to the cutting knife by 1).3 - the distal end of the bent cutting knife caught on the inner wall of the tube, but the cutting knife was forcibly attempted to be ejected, which resulted in the knife penetrating the tube as it was.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : - when using the kd-v451m, and any irregularity is detected on the coated surface of the cutting knife, immediately stop using it.Otherwise, patient injury such as perforation, bleeding, and mucous membrane damage could occur.- when resistance to extension of the cutting knife is encountered, lower the forceps elevator to the position that allows you to easily extend the knife.Forcibly extension of the knife may cause patient injury such as bleeding.This may also damage the instrument.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.
Event or Problem Description
The customer reported the single use 3-lumen needle knife protruded from the side of the sheath and not the tip.The issue occurred during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure and was confirmed on the endoscope screen.A similar device was used to complete the procedure.There was no reported patient harm or impact due to this event.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Common Device Name: SINGLE USE 3-LUMEN NEEDLE KNIFE
• 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: 18593904
• Report Number: 9614641-2024-00197
• Device Sequence Number: 20547506
• Product Code: KNS
• UDI-Device Identifier: 04953170382710
• UDI-Public: 04953170382710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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-V451M
• Device Lot Number: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• 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: 10/26/2022
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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
• Patient Sex: Unknown