MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650Q
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the electrosurgical knife wire fractured and fell into the patient's intestinal lumen during a during a therapeutic endoscopic submucosal dissection (esd).The device was not retrieved as it was determined that it would pass naturally and the procedure was prolonged greater than thirty minutes while the patient was under general anesthesia.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the completed investigation.The device was returned to olympus for inspection and the customer's reported issue was confirmed, the cutting knife was broken and the fractured part was burnt and melted.Based on the results of the investigation, the reported issue likely occurred due to the following: 1) due to the factor described below, spark discharge between the tissue and the cutting knife occurred during output activation.The output setting for activation was too high.·the electrosurgical unit was used in the coagulation mode.·the output activation time was too long.2) spark discharge occurred, and the part of the cutting knife became hot instantly.As a result, the strength of the cutting knife decreased.Also, the cutting knife was scorched.3) during tissue incision, a load was applied to the cutting knife which has the reduced strength.This might have caused the cutting knife to break.However, the exact cause of spark discharge generation could not be identified.Therefore, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Common Device Name: SINGLE USE ELECTROSURGICAL 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: 21583900
• Report Number: 9614641-2025-00298
• Device Sequence Number: 8757222
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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-650Q
• Device Lot Number: 3YK(B7TCE)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown