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

Catalog Number 130309A

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

The customer reported that the 130309a, goldline, button, holster was being used on (b)(6) 2023.Tery sound on esu goes off even when goldline pencil buttons are not being pushed.Customer says some of the pencils in the batch have done it but don't believe the bovie was actually firing/heating up during misfire tone.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

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.H3 other text : device not yet received.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review shows a total of 20 devices for this lot number and failure mode.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 review of complaint history revealed there has been a total of (b)(4) report, regarding (b)(4), for this device family and failure mode.During this same time frame (b)(4) 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(b)(4).Per the instructions for use, the user is advised the following: 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.The ifu also states to use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the (b)(6), goldline, button, holster was being used on (b)(6)2023 and the ¿cautery sound on esu goes off even when goldline pencil buttons are not being pushed.Customer says some of the pencils in the batch have done it but don't believe the bovie was actually firing/heating up during misfire tone.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: GOLDLINE, BUTTON, HOLSTER
• Type of Device: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18120799
• MDR Text Key: 328018538
• Report Number: 3007305485-2023-00239
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405056151
• UDI-Public: (01)30653405056151(17)280828(10)202308305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 130309A
• Device Lot Number: 202308305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic