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	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the knife of the single use 3-lumen needle knife pierced the sheath and protruded.The issue occurred when the device was inserted into a scope and the physician tried to project the incision knife at the tip.A similar 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 wire sheathing had turned over toward the proximal side.The report is being submitted due to the defect found during evaluation.
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the dissection knife was retracted into the tube.When the slider was pushed and pulled, the dissection knife protruded from the tip of the tube.The protruding dissection knife had no wire sheathing.When operating, the slider with the tube tip was bent and the incision knife protruded from the tip.No abnormalities were found on the other side of the tube near the tip.No leakages were found.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Since the broken knife could not be replicated and there were no cracks or tears in the distal end tube, a definitive root cause of the broken distal end could not be determined.Although the root cause of the peeled cover and exposed knife could not be determined, the cutting knife was moved while the end face of the coated portion of the wire was caught on something.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.

• 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: 18569545
• Report Number: 9614641-2024-00160
• Device Sequence Number: 20590774
• Product Code: KNS
• UDI-Device Identifier: 04953170244148
• UDI-Public: 04953170244148
• 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): Unknown
• 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): 01/24/2024

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: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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