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

Model Number	60-7510-005
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-7510-005 goldvac integrated smoke pencil, pushbutton (10/cs) was being used on (b)(6) 2023 during a general surgery procedure and ¿this is a safety concern as cautery malfunctioned mid case.The cautery turned on without activating any buttons cut or coag /foot pedal.Patient was burned on the abdomen.¿ the procedure was completed with an alternate unknown device.After further assessment it was found the patient received a 1st degree burn and no medical/surgical intervention was required for the burn.Also, it was found that "the device was on patient, not in use when it got activated." the "patient is doing ok".It was reported that no prolonged hospitalization was required "for this reason".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-7510-005 goldvac integrated smoke pencil, pushbutton (10/cs) was being used on 4apr23 during a general surgery procedure and ¿this is a safety concern as cautery malfunctioned mid case.The cautery turned on without activating any buttons cut or coag /foot pedal.Patient was burned on the abdomen.¿ the procedure was completed with an alternate unknown device.After further assessment it was found the patient received a 1st degree burn and no medical/surgical intervention was required for the burn.Also, it was found that "the device was on patient, not in use when it got activated.".The "patient is doing ok".It was reported that no prolonged hospitalization was required "for this reason".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: h10 evaluation statement now reads: 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 7550 (c8406) system.The handpiece was plugged into the unit and immediately activated without depressing the button.Furthermore, the device was disassembled to find no abnormalities or defects within the internal components.The cut and coag are comparatively different when clicking and one feels like it's sticking; however, it is undetermined what caused the button to stick.Manufacturer narrative: 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 7550 (c8406) system, the complaint was confirmed.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 4 reports, regarding 4 devices, for this device family and failure mode.During this same time frame 701,280 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 0.000006.Per the instructions for use, the user is advised the following: 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 (10/cs) was being used on (b)(6) 2023 during a general surgery procedure and ¿this is a safety concern as cautery malfunctioned mid case.The cautery turned on without activating any buttons cut or coag /foot pedal.Patient was burned on the abdomen.¿ the procedure was completed with an alternate unknown device.After further assessment it was found the patient received a 1st degree burn and no medical/surgical intervention was required for the burn.Also, it was found that "the device was on patient, not in use when it got activated.".The "patient is doing ok".It was reported that no prolonged hospitalization was required "for this reason".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
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 7550 (c8406) system, the complaint was confirmed.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: 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: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 16814161
• Report Number: 3007305485-2023-00092
• Device Sequence Number: 5692334
• Product Code: GEI
• UDI-Device Identifier: 30653405056335
• UDI-Public: (01)30653405056335(17)250206(10)202302074
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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 Expiration Date: 02/06/2025
• Device Model Number: 60-7510-005
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 202302074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 06/19/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/08/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic