MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDLINE,BUTTON,HOLS,U/C,NSB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	131318A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
Event or Problem Description
The distributor reported on behalf of the customer that the 131318a, goldline,button,hols,u/c,nsb ¿was faulty and caused a burn to a patient.¿ further assessment has been sent; however, no new information has been obtained.This report is being raised on the basis of injury due to unknown degree of burn.
Additional Manufacturer Narrative
Received one 131318a in unoriginal package.Lot number was not verified.Performed a visual inspection, the top of the electrode seemed burned.Performed a functional inspection using the esu system 7550 (c8406), the device functioned as intended.In addition, the photographs provided from the evaluation, it was determined that the electrode tip was not a conmed device.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: inspect and test each device before use.These devices should be inspected before each use.Visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts.Broken or significantly bent connector contacts.Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.Verify that the electrode is fully and securely seated in the handpiece before use.Always place unused associated electrosurgical accessories in a safe insulated location such as a holster when not in use.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the 131318a, goldline, button, hols, u/c, nsb ¿was faulty and caused a burn to a patient.¿ further assessment has been sent; however, no new information has been obtained.This report is being raised on the basis of injury due to unknown degree of burn.

• Brand Name: GOLDLINE,BUTTON,HOLS,U/C,NSB
• 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16743555
• Report Number: 3007305485-2023-00081
• Device Sequence Number: 15113806
• Product Code: GEI
• UDI-Device Identifier: 20653405056321
• UDI-Public: (01)20653405056321(11)220808(30)250(10)202208085
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 131318A
• Device Lot Number: 202208085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic