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

Catalog Number 60-8005-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 07/14/2022

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the 60-8005-001, system 5000-english panel-120v, was being used during a cesarean section procedure on (b)(6) 2022 when it was reported, ¿while using an electrosurgery pencil to buzz a debakey grasper or just an electrosurgery pencil, users got zapped.Gloves had holes and claim to have burn surgeons' fingers.¿.The procedure was completed as planned with a 5-minute delay.There was no report of medical intervention, or hospitalization for the user.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the reporter felt the user receive more of a ¿zap¿ then a burn.The degree of burn was not indicated.The reporter did not indicate a malfunction of the 60-8005-001 device.This report is being raised on the basis of injury due to unknown degree of burn to the user.

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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet returned.

Manufacturer Narrative

Evaluation found the software required updating, output contacts in very poor condition and all output ports are dark, all 9 contacts require the upgrade to the new design and the 4 bumper rubber is missing.Additionally, the pm was overdue.Parts were replaced and the device recalibrated; the device was function tested and met all specifications.The manufacturing documents from the device history record have not been reviewed because the device has been in the field for more than 12 months.The service history was reviewed, and no data was found.At the time of the event, the device was 117 months of age.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 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 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 the equipment be read, understood and followed in order to ensure safe and effective use of the equipment.The ifu also advises the user that the system 5000 should be performance tested by a hospital qualified biomedical technician at least every year.Additionally, the recommended conmed service interval for this device is 12 months.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 60-8005-001, system 5000-english panel-120v, was being used during a cesarean section procedure on 14jul22 when it was reported, ¿while using an electrosurgery pencil to buzz a debakey grasper or just an electrosurgery pencil, users got zapped.Gloves had holes and claim to have burn surgeons' fingers.¿.The procedure was completed as planned with a 5-minute delay.There was no report of medical intervention, or hospitalization for the user.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the reporter felt the user receive more of a ¿zap¿ then a burn.The degree of burn was not indicated.The reporter did not indicate a malfunction of the 60-8005-001 device.This report is being raised on the basis of injury due to unknown degree of burn to the user.

• Brand Name: SYSTEM 5000-ENGLISH PANEL-120V
• Type of Device: 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: 15208393
• MDR Text Key: 297680843
• Report Number: 3007305485-2022-00126
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-8005-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEBAKEY GRASPER; DEBAKEY GRASPER; ELECTROSURGERY PENCIL; ELECTROSURGERY PENCIL
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic