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

Catalog Number	60-7520-005
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-7520-005, rocker switch electrosurgical smoke evacuation handpiece, was being used during a laparotomy procedure on (b)(6) 2024 when it was reported, ¿i received an email form the hospital stating that the rocker switch fell off into the abdomen and was retrieved by the surgeon." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with no delay reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-7520-005, rocker switch electrosurgical smoke evacuation handpiece, was being used during a laparotomy procedure on (b)(6) 24 when it was reported, ¿i received an email form the hospital stating that the rocker switch fell off into the abdomen and was retrieved by the surgeon.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with no delay reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned used device 60-7520-005 verified that the rocker switch detached from the body of the goldvac pencil.Evaluations were performed per print.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be that the item was not inspected for damage before use.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 one complaint, regarding one device, for this device family and failure mode.During this same time frame 701,830 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 0.000001.Per the instructions for use, the user is advised to 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, or significant discolorations.We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20585743
• Report Number: 3007305485-2024-00166
• Device Sequence Number: 8575620
• Product Code: GEI
• UDI-Device Identifier: 30653405056342
• UDI-Public: (01)30653405056342(17)2600708(10)202407084
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 07/08/2026
• Device Catalogue Number: 60-7520-005
• Device Lot Number: 202407084
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic