MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-7510-005
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the 60-7510-005, goldvac integrated smoke pencil pushbutton was being used on (b)(6) 2023 and the ¿cautery would not turn off.No buttons pushed and still on burn mode.Burned skin + drape before we noticed sparking.".Further assessment has been requested; however, no new information has been obtained.The reporter responded the surgeon is out of town until august and will respond with answers to assessment questions at that time.This report is being raised on the basis of injury due to unknown degree of burn.
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
Update: received one 60-7510-005 in original opened package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406), the complaint wasn't confirmed.The device functioned as intended.Codes: type of investigation, investigation findings and investigation conclusion were updated with results of the evaluation.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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Update: per reporter: "unfortunately i have bad news.Several staff of the department have been asked for details to help respond to your questions and nobody has any information for us.I am unable to get you any further details to the particular incident.".The customer reported that the 60-7510-005, goldvac integrated smoke pencil pushbutton was being used on (b)(6) 2023 and the ¿cautery would not turn off.No buttons pushed and still on burn mode.Burned skin + drape before we noticed sparking.".Further assessment has been requested; however, no new information has been obtained.The reporter responded the surgeon is out of town until august and will respond with answers to assessment questions at that time.This report is being raised on the basis of injury due to unknown degree of burn.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 60-7510-005, goldvac integrated smoke pencil pushbutton was being used on (b)(6) 2023 and the ¿cautery would not turn off.No buttons pushed and still on burn mode.Burned skin + drape before we noticed sparking.".Further assessment has been requested; however, no new information has been obtained.The reporter responded the surgeon is out of town until august and will respond with answers to assessment questions at that time.This report is being raised on the basis of injury due to unknown degree of burn.

• Brand Name: GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS)
• 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: 17320853
• Report Number: 3007305485-2023-00160
• Device Sequence Number: 6573455
• Product Code: GEI
• UDI-Device Identifier: 30653405056335
• UDI-Public: (01)30653405056335(17)250410(10)202304114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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 Expiration Date: 04/10/2025
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 202304114
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 08/29/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/15/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic