MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDVAC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-7510-005
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure 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, push button electrosurgical smoke evacuation handpiece was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿the cut function was engaged for the entire time it was plugged in and even though the surgeon was pressing the coag button, it was cutting.This caused excess bleeding and skin lacerations before it was discovered and switched.¿.The procedure was completed with the use of an alternate device and a two-minute delay.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported injury of excess bleeding and skin lacerations.
Additional Manufacturer Narrative
Reported event of ¿cut function was engaged for the entire time it was plugged in and even though the surgeon was pressing the coag button, it was cutting¿ was inconclusive.Examination of returned used device 60-7510-005 found that the device worked as intended.Examination was done with system 5000.A root cause cannot be determined; however, based upon evaluation of the device, and additional information received from sales, the original pencil was discarded and the customer sent back a different pencil.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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised that these devices should never be used when: there is visible evidence of damage to the exterior of the device, such as cracked or damaged plastic or connector damage.These devices fail the inspection described herein.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, or significant discolorations.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-7510-005, push button electrosurgical smoke evacuation handpiece was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿the cut function was engaged for the entire time it was plugged in and even though the surgeon was pressing the coag button, it was cutting.This caused excess bleeding and skin lacerations before it was discovered and switched.¿.The procedure was completed with the use of an alternate device and a two-minute delay.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported injury of excess bleeding and skin lacerations.

• Brand Name: GOLDVAC
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20964577
• Report Number: 3007305485-2024-00196
• Device Sequence Number: 15568958
• Product Code: GEI
• UDI-Device Identifier: 30653405056335
• UDI-Public: (01)30653405056335(17)260719(10)202407194
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 07/19/2026
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 202407194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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