MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT GOLDVAC PUSH BUTTON INTEGRATED SMOKE PENCIL; GOLDVAC PENCIL

Catalog Number	60-7510-005
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected for evaluation and a supplemental report will be filed upon the completion of the device evaluation and complaint investigation.
Event or Problem Description
A c-section was going to be performed with the assistance of a goldvac integrated smoke pencil.The goldvac cautery pencil was placed in the bag of the c-section drape, where it turned on.The surgeon picked it up and it did not stop; it kept working without the buttons being pressed.To turn off the golvac pencil, it had to be unplugged from the machine.The patient suffered a burn on her thigh.This event occurred during pre-op testing, not during surgery.Four attempts to gather more information from the user facility and reporter were made.The degree of the burn, procedure completion/delays, or additional treatments are unknown, to date.This report is made on the basis of a reported malfunction, with potential for injury with reoccurrence.
Additional Manufacturer Narrative
Correction: corrected unique identified number manufacture narrative: the used device was returned for evaluation with its original opened packaging.Device catalog and ref numbers were verified.No electrode was received with the device.Visual inspection found the device to perform as intended.The insulation was observed to be intact.The handpiece casing was separated to inspect the inner components.The outer blue wiring insulation was breached on the distal end, however; the inner wirings insulation was not breached.No defects were observed with the devices' cut, coag, ground wiring and pcb board soldering.Functional testing found the device to perform as intended.The device was actuated with a system 7500 and a goldvac accessory electrode.The reported device was observed to activate a normal response when the coag and cut buttons were pressed with normal pressure, even while agitating the plug, wiring and handpiece.Auto activation or further defects were not observed.A digital multimeter was used to inspect continuity of the device cut and coag wiring.No continuity was observed for this testing.Defects potentially causing a short circuit or auto activation were not observed.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.A historical review of complaint data revealed 10 similar complaints of which 5 devices were confirmed in the past two years.In the same timeframe 890,193 units have been sold worldwide, making the rate of occurrence of this failure 0.001 percent.The instructions for use advise 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.These devices should never be used when: in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide, or in oxygen-enriched environments.Never allow cables connected to these devices to be in contact with skin of the patient or the operator during electrosurgical activations.Inspect and test each device before use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: GOLDVAC PUSH BUTTON INTEGRATED SMOKE PENCIL
• Common Device Name: GOLDVAC PENCIL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 31 136; MX CP 31136
• MDR Report Key: 6836362
• Report Number: 3007305485-2017-00193
• Device Sequence Number: 41463
• Product Code: GEI
• UDI-Device Identifier: 20653405056338
• UDI-Public: (01)20653405056338(17)190403(10)201704035
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: Other
• Device Expiration Date: 04/03/2019
• Device Catalogue Number: 60-7510-005
• Device Lot Number: 201704035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1