MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDVAC RS SMOKE PENCIL; GOLDVAC PENCILS

Catalog Number	60-7520-005
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation in its original opened packaging.The lot and catalog numbers were verified.Visual inspection did not find any defects.Functional testing of the device with an esu system 7500 observed both cut and coag buttons to activate as intended.Auto-activation could not be recreated, therefore, the report was unable to be confirmed.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.Of the lot containing 1,000 units, this is the only complaint for this product and failure mode.A two-year review of complaint history revealed a total of 11 complaints for this product and failure mode.(b)(4).The instructions for use advises the user of the following.- always place unused associated electrosurgical accessories in a safe insulated location such as the provided holster when not in use.- unit should be inspected before each use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
A conmed representative reported on behalf of a user facility that during surgery the 60-7520-005 goldvav smoke pen activated without the switch being pressed.The smoke evacuator was also reported to operate continuously.To date, no additional information has been made available regarding patient status or the procedure.No patient injury was reported.This report is raised based on a reported malfunction with potential for injury with recurrence.

• Brand Name: GOLDVAC RS SMOKE PENCIL
• Common Device Name: GOLDVAC PENCILS
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, CP 11 36; MX CP 1136
• MDR Report Key: 7038803
• Report Number: 3007305485-2017-00250
• Device Sequence Number: 966292
• Product Code: GEI
• UDI-Device Identifier: 00653405056341
• UDI-Public: (01)00653405056341(17)190628(10)201706285
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 06/28/2019
• Device Catalogue Number: 60-7520-005
• Device Lot Number: 201706285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1