MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER RFA GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/04/2023

Event Type  Injury  

Event Description

During the procedure (bilateral lumbar 4-5 and lumbar 5-sacral 1 radiofrequency ablation using the stryker rfa generator, the machine read an error code that stated the electrodes were disconnected.After reattaching the electrodes, the machine began to work and the procedure was completed as normal.After the procedure ended the stryker bovie pad (ref#0406-650-205) was removed from the patient.A burn was seen under the bovie pad on the patient's left posterior thigh.The surgeon was notified and assessed the site.Antibiotic ointment was placed on the burn.The patient returned to see the surgeon for a follow-up visit.The surgeon stated that the burn was healing up nicely.Reference report mw5147959.

• Brand Name: STRYKER RFA GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 18100830
• MDR Text Key: 328110185
• Report Number: MW5147960
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American