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	06/06/2023
Type of Reportable Event	Serious Injury
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.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-7510-005, goldvac integrated smoke pencil pushbutton was being used on (b)(6) 2023 during a c-section and myomectomy procedure and the ¿patient burned with cautery going off without engaging the button¿.The procedure was completed with a 10 minute delay to "open few cauteries".Further assessment found the device was not being used at the time of the burn, "it wasn`t used but left on patient abdomen when activated.".A total of three devices (60-7510-005) with 2 lot numbers (202302234 and 202303035) were used in this procedure and it is not known which lot was involved in the burn."staff opened three cauteries and incident happened with one of these lots as we can not identify.".The degree of the burn the patient received is not known.It is not known if medical/surgical intervention or prolonged hospitalization was required for the patient.The electrical surgical unit used was a valleylab ft10 and will be listed as a concomitant device.This report is being raised on the basis of injury due to unknown degree of burn.
Additional Manufacturer Narrative
Received two 60-7510-005 in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the esu system 7550 (c8406), the device functioned as intended and did not continuously run.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.Always place unused associated electrosurgical accessories in a safe insulated location such as the provided 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 sales representative reported on behalf of the customer that the 60-7510-005, goldvac integrated smoke pencil pushbutton was being used on (b)(6) 2023 during a c-section and myomectomy procedure and the ¿patient burned with cautery going off without engaging the button¿.The procedure was completed with a 10 minute delay to "open few cauteries".Further assessment found the device was not being used at the time of the burn, "it wasn`t used but left on patient abdomen when activated.".A total of three devices (60-7510-005) with 2 lot numbers (202302234 and 202303035) were used in this procedure and it is not known which lot was involved in the burn."staff opened three cauteries and incident happened with one of these lots as we can not identify.".The degree of the burn the patient received is not known.It is not known if medical/surgical intervention or prolonged hospitalization was required for the patient.The electrical surgical unit used was a valleylab ft10 and will be listed as a concomitant device.This report is being raised on the basis of injury due to unknown degree of burn.
Event or Problem Description
The sales representative reported on behalf of the customer that the (b)(4), goldvac integrated smoke pencil pushbutton was being used on (b)(6) 2023 during a c-section and myomectomy procedure and the ¿patient burned with cautery going off without engaging the button¿.The procedure was completed with a 10 minute delay to "open few cauteries".Further assessment found the device was not being used at the time of the burn, "it wasn`t used but left on patient abdomen when activated.".A total of three devices ((b)(4)) with 2 lot numbers (202302234 and 202303035) were used in this procedure and it is not known which lot was involved in the burn."staff opened three cauteries and incident happened with one of these lots as we can not identify.".The degree of the burn the patient received is not known.It is not known if medical/surgical intervention or prolonged hospitalization was required for the patient.The electrical surgical unit used was a valleylab ft10 and will be listed as a concomitant device.This report is being raised on the basis of injury due to unknown degree of burn.
Additional Manufacturer Narrative
Correction: received one (b)(6) in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the esu system 7550 ((b)(6)), the device functioned as intended and did not continuously run.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.A two-year review of complaint history revealed there has been a total of 6 reports, regarding (b)(4), for this device family and failure mode.During this same time frame (b)(4) 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: inspect and test each device before use.Always place unused associated electrosurgical accessories in a safe insulated location such as the provided holster when not in use.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: 17325830
• Report Number: 3007305485-2023-00165
• Device Sequence Number: 14863236
• Product Code: GEI
• UDI-Device Identifier: 30653405056335
• UDI-Public: (01)30653405056335(10)250222(17)202302234
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

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: 02/22/2025
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 202302234
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/30/2023; 09/06/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/30/2023; 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VALLEYLAB FT10.; VALLEYLAB FT10.; VALLEYLAB FT10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic