MAUDE Adverse Event Report: Conmed SYSTEM 2450; Electrosurgical, cutting & coagulation & accessories

Catalog Number	60-2450-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction

• Brand Name: SYSTEM 2450
• Common Device Name: Electrosurgical, cutting & coagulation & accessories
• Manufacturer (Section D): Conmed; 525 french rd; utica NY 13502
• Manufacturer (Section G): Consolidated Medical Equipment Company; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 525 french rd; utica, NY 13502 ; +1(865)388-1978
• MDR Report Key: 50236293
• Report Number: 3007305485-2026-00154
• Device Sequence Number: 18706436
• Product Code: GEI
• UDI-Device Identifier: 10653405061526
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: Health Professional
• Device Catalogue Number: 60-2450-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 237 LB