MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT GOLDVAC PB SMOKE PENCIL; GOLDVAC PENCIL

Catalog Number 60-7510-005

Device Problem Excessive Heating (4030)

Patient Problem Skin Irritation (2076)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

The reported device, 60-7510-005, goldvac smoke pencil, 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported that the 60-7510-005, goldvac pencil, during a bilateral orchidopexy procedure on (b)(6) 2019, inadvertently transferred energy from the pencil through the assistant to the patient.This caused the assistant to feel heat in his third finger, which was holding the patient's scrotal skin in the inguinal area.The assistant was holding an adson tissue forceps at the time of transference.The assistant changed his glove to be safe, there was no hole noted in the glove.The assistant di not receive any injury, however, he/she noticed the heat transference caused "erythematous" redness and irritation with a defined border to the patient's adjacent skin, approximately 2cm x 1cm, and a dark mark appeared at the patient's distal end of the spermatic cord.The patency of the spermatic cord was not checked, however the testicle was noted to be pink indicating good blood flow.The patient was on a mega dyne pad in lieu of using a grounding pad.The procedure was completed with no delay.This report is being raised based on a device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

To date, the reported device has not been returned to conmed for evaluation.Should the device be returned an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.Otherwise this filing will stand as the final report.The manufacturing documents from the device history record could not be performed since no lot number was provided.(b)(4).Per the instructions for use, the user is advised the following; - use the lowest possible settings on the associated electrosurgical unit capable of achieving the desired surgical effect.- activation time should be as short as possible.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 PB SMOKE PENCIL
• Type of Device: GOLDVAC PENCIL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 8312822
• MDR Text Key: 137295963
• Report Number: 3007305485-2019-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K081634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-7510-005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 25