MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SYSTEM 5000, SYMBOLS FRONT PANEL, INTERNATIONAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-8005-002
Medical Device Problem Codes	Noise, Audible (3273); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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 sales representative reported on behalf of a customer that the 60-8005-002, system 5000, symbols front panel, international device was being used during an unnamed procedure on (b)(6) 2024 and, ¿after 10-15 min.Of use, conmed 130317 handpiece connected and megadyne megasoft plate connected, the electrosurgical unit begins to emit a loud.The cut and the clot activate on their own.Turn the machine off and on again several times: the defect is repeated even when changing accessories.¿.Follow-up assessment found ¿the reusable pencil used is a normal conmed accessory and that the only connected accessory different from the usual was the large dispersive electrode.The 130317 and the megadyne megasoft plate devices did not cause any problems and worked correctly.¿.There was no report of delay to the procedure or of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The 130317, pencil,button,reusable,10/case will be listed as a concomitant device.There are no allegations against it.
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-8005-002, system 5000, symbols front panel, international device was being used during an unnamed procedure on (b)(6) 2024 and, ¿after 10-15 min.Of use, conmed 130317 handpiece connected and megadyne megasoft plate connected, the electrosurgical unit begins to emit a loud.The cut and the clot activate on their own.Turn the machine off and on again several times: the defect is repeated even when changing accessories.¿.Follow-up assessment found ¿the reusable pencil used is a normal conmed accessory and that the only connected accessory different from the usual was the large dispersive electrode.The 130317 and the megadyne megasoft plate devices did not cause any problems and worked correctly.¿.There was no report of delay to the procedure or of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The 130317, pencil,button,reusable, 10/case will be listed as a concomitant device.There are no allegations against it.
Additional Manufacturer Narrative
Evaluation of the device found that it functioned as intended.A hand piece was connected to the right and left ports and never ran on its own; no fault found.The device was calibrated and passed final testing.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 previous data was found.(b)(4).Per the operator's manual the user is advised that safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator.It is important that the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment.Only properly qualified and trained operators should perform electrosurgery.The operator and their support personnel must be diligent in assuring that the esu is properly configured and that proper settings are used.The esu must be located to assure the operator or their support personnel can readily verify the settings.The system 5000 is capable of causing physiological effects, including burns to the patient or operator.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SYSTEM 5000, SYMBOLS FRONT PANEL, INTERNATIONAL
• 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: 19322545
• Report Number: 3007305485-2024-00075
• Device Sequence Number: 17731995
• Product Code: GEI
• UDI-Device Identifier: 10653405040200
• UDI-Public: (01)10653405040200(11)240216
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 60-8005-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0845,MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE; 0845,MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE; 130317, PENCIL,BUTTON,REUSABLE,10/CASE; 130317, PENCIL,BUTTON,REUSABLE,10/CASE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic