MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number	KD-645L
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the triangle tip of the electrosurgical knife broke off during an unspecified therapeutic procedure due to the non-olympus generator output being set too high.The broken piece was retrieved from the patient successfully and the procedure was completed using a similar device.There were no reports of further patient harm.
Event or Problem Description
This report is being supplemented to update d4 (lot no.) and d9.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• 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
• MDR Report Key: 19175570
• Report Number: 2429304-2024-00230
• Device Sequence Number: 11711697
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024
• Report Date (Section F): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-645L
• Device Lot Number: 43K 12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown