MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY HYFRECATOR 2000, 115V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 7-900-115

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/11/2023

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 7-900-115, hyfrecator 2000, 115v was being used on (b)(6) 2023 and the patient was burned.Further assessment was sent; however, the response was "unfortunately, the (b)(6) privacy officer has advised that i not provide the patient or event information as it is protected under 38 u.S.C 570¿.This report is being raised due to the reported injury of burn of unknown degree.

Event Description

The customer reported that the 7-900-115, hyfrecator 2000, 115v was being used on (b)(6) 2023 and the patient was burned.Further assessment was sent; however, the response was "unfortunately, the va privacy officer has advised that i not provide the patient or event information as it is protected under 38 u.S.C 570¿.This report is being raised due to the reported injury of burn of unknown degree.

Manufacturer Narrative

Evaluation found that the unit was checked and met all acceptance criterion; no fault found.The pm was completed; the device was final tested and met all specifications.The service history was reviewed, and no previous service data was found.A device history record review was not conducted as the device has been in the field for more than 12 months.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices 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: the tips of recently activated accessories may be hot enough to burn the patient or ignite flammable material.Temporarily unused active electrodes should be stored in the holder on the hyfrecator® 2000 or in an electrically insulated, flame resistant container to prevent injury due to hot tips or accidental activation of the footswitch.The unused active electrode should never be placed on the patient.The ifu also advises the user that when used, the neutral electrode (patient plate) should be reliably attached with the entire surface area in contact with the patient¿s body and as close to the operating field as possible.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HYFRECATOR 2000, 115V
• 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: 18466439
• MDR Text Key: 332382623
• Report Number: 3007305485-2024-00003
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970493
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7-900-115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic