MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SYSTEM 2450; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-2450-120
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
A customer reported that the 60-2450-120, system 2450, 120v device was being used during an unnamed procedure on approximately (b)(6) 2024, and ¿the doctor was using the unit he received a shock¿ there was no injury to the doctor.Doctor received a shock while using unit.No marks left from shock and no patient injury¿.There was no delay to the procedure, and no report of medical or surgical intervention, or extended hospitalization for the patient or user.A good faith effort was made to obtain further information from the reporter; however, no further details have been provided to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A customer reported that the 60-2450-120, system 2450, 120v device was being used during an unnamed procedure on approximately (b)(6) 2024, and ¿the doctor was using the unit he received a shock¿ there was no injury to the doctor.Doctor received a shock while using unit.No marks left from shock and no patient injury¿.There was no delay to the procedure, and no report of medical or surgical intervention, or extended hospitalization for the patient or user.A good faith effort was made to obtain further information from the reporter; however, no further details have been provided to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An evaluation of the returned device found no fault.The evaluation was completed and final tested.The unit met all specifications.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed, and no prior data was found.A two-year review of complaint history revealed there has been a total of six reports, regarding six devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: to avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.Improperly connecting test equipment can cause electric shock and destruction of equipment.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SYSTEM 2450
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20039037
• Report Number: 3007305485-2024-00119
• Device Sequence Number: 6508525
• Product Code: GEI
• UDI-Device Identifier: 10653405061526
• UDI-Public: (01)10653405061526(11)171101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Catalogue Number: 60-2450-120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic