MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY THE SYS 5000-FULL, ENG FP, INT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-8018-SYS
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 60-8018-sys, the sys 5000-full, eng fp, int, during post-op on (b)(6) 2024 was reported as, ¿after case was finished and machine was unplugged, scrub nurse touched the prongs of the power cable and received mild shock.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
An evaluation of the returned device could not confirm the reported problem.The unit passed main leakage.The unit power accuracy and open circuit voltage meets specifications.Additional problems found that the front bezel is broken.The preventive maintenance was overdue.A device history record (dhr) review was not conducted as the device has been in the field greater than 12 months.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 5 complaints, regarding 5 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: there are no user serviceable parts in this equipment.Improper servicing of the equipment could result in improper operation and present a risk of electric shock.Avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 60-8018-sys, the sys 5000-full, eng fp, int, during post-op on (b)(6) 2024 was reported as, ¿after case was finished and machine was unplugged, scrub nurse touched the prongs of the power cable and received mild shock.¿ there was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: THE SYS 5000-FULL, ENG FP, INT
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18683998
• Report Number: 3007305485-2024-00023
• Device Sequence Number: 7242656
• Product Code: GEI
• UDI-Device Identifier: 20653405040979
• UDI-Public: 20653405040979
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K020186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: 60-8018-SYS
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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