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

Catalog Number 130309A

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/02/2023

Event Type  Injury  

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.

Event Description

The customer reported that the 130309a, goldline, button, holster device was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿patient was burned¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The current status of the patient was reported as ¿the patient will be fine¿.There was no report of medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient being diagnosed with unknown degree of burn.

Event Description

The customer reported that the 130309a, goldline, button, holster device was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿patient was burned.¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The current status of the patient was reported as ¿the patient will be fine¿.There was no report of medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient being diagnosed with unknown degree of burn.

Manufacturer Narrative

During the evaluation it was found that the blade was bent, but this did not affect the functionality of the device.Received one 130309a in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the blade is bent.Performed a functional inspection, the device functions as intended when the buttons are pressed.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.(b)(4).Per the instructions for use, the user is advised that 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.These devices fail the inspection described herein.In the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o), or in oxygen-enriched environments.Use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17974511
• MDR Text Key: 326126043
• Report Number: 3007305485-2023-00225
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405056151
• UDI-Public: (01)30653405056151(17)280626(10)202306285
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130309A
• Device Lot Number: 202306285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic