MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SYSTEM 5000-ENGLISH PANEL-120V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-8005-001
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: the initial filing was reported under the wrong "year" marker.The initial mdr, reported on 01/07/2021, within the 30 day time frame was reported as report number 3007305485-2020-00003.The actual number of the report was 3007305485-2021-00003.This filing stands as the correction for the typo that occurred with the "year" in the report number.This is the initial and final mdr report combined.Manufacturer narrative: lfc were clear.Power accuracy and rf leakage meets specifications.Unit was final tested and met all acceptance criteria.Pm was not overdue.Returning with power cord.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 relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 15 devices, for this device family and failure mode.During this same time frame 31,489 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 0.0005.Per the instructions for use, the user is advised to exercise care when relocating the esu to avoid electrostatic charge buildup in the presence of flammable materials, as there is a risk of igniting these materials if a spark should occur.Ensure the power switch if off, and then connect the power cable to a properly grounded and polarized mating power receptacle.Do not connect a dispersive electrode at this time.Inspect and connect the desired monopolar or bipolar accessories to the connectors on the front of the esu.Warning always stow unused accessories in a safe, insulated location such as a holster.Do not place active accessories on the patient.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created from a repair service request for device, 60-8005-001, where the customer has reported "sparking at the tip of the bipolar forceps" in the sterile field during an unknown procedure on an unknown date.Further assessment information advised that this sparking was an arc.The customer stated that the device was changed out for an alternate device and the forceps no longer sparked.The procedure was completed with no report of injury, medical intervention or hospitalization to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SYSTEM 5000-ENGLISH PANEL-120V
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11344902
• Report Number: 3007305485-2021-00003
• Device Sequence Number: 10944792
• Product Code: GEI
• UDI-Device Identifier: 10653405040194
• UDI-Public: (01)10653405040194(11)190429
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K020186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 60-8005-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1