MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. Single Use Electrosurgical Knife KD-655

Model Number	KD-655U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the single use electrosurgical knife to the investigation center for a separate issue.During the device analysis, the investigator indicated that the knife head was fractured.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: Single Use Electrosurgical Knife KD-655
• 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 ; +1(508)207-7661
• MDR Report Key: 50524240
• Report Number: 9614641-2026-00863
• Device Sequence Number: 10703301
• Product Code: KNS
• UDI-Device Identifier: 04953170377532
• UDI-Public: 04953170377532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: Other
• Device Model Number: KD-655U
• Device Lot Number: 62K
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2026
• 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