MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE BOVIE TIP INSULATED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0012AM

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

While using a pencil bovie during a breast reconstruction revision surgery, the pencil tip arced and left burning on the upper mid skin of the left breast approximately 1.5cm.The sparking was immediately noticeable by the surgeon & periop team and procedure was halted.The sheath of the pencil tip is burned through.New pencil tip and bovie and esu (electrosurgical unit) were obtained to continue surgery.Surgeon is planning to remove the burned portion of skin.Device being used at the time of the event was a megadyne bovie pencil that came inside the patewood major breast surgery "pack".Confirmed with the surgeon: prep done as per policy at start of case.No irrigation or other substance in use at time of electrical "arc" that could contribute to the "event": using saline for irrigation in a small area on the breast.Silicone implant and residual silicone had been removed by surgeon and irrigation had taken place prior to the "arc".Physician reports using both longer and short version of insulated bovie tips during surgery case confirmed with the surgical technician the following: she does not use a hemostat or other instrument to remove bovie tip from pen: uses a 4x4 sponge if needed for traction to remove/replace bovie tips in the pen.Confirmed with team: all megadyne bovie pencils used come in the surgical pack and are not pulled from surgery supplies.Megadyne bovie pencil tips are utilized.Confirmed with clinical engineering: the esu is a "loaner" and not in inventory for (b)(6) health clinical engineering to perform preventative maintenance.Last pm 6/22? see photos, may be as long as 6/20.Clinical engineering performed preventative maintenance on the esu involved in this surgery and noted the unit passed inspection.Engineering notified the vendor of the "loaner" at the facility and requested that the unit be retrieved by the vendor.Confirmed in the emr: pre-surgery fire safety and surgery safety checklist were performed/documented in emr by team st confirmed verbally this practice was followed for this surgical case.

• Brand Name: MEGADYNE BOVIE TIP INSULATED
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.
• MDR Report Key: 17315763
• MDR Text Key: 319051845
• Report Number: MW5119316
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0012AM
• Device Lot Number: SPMEUX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: PATEWOOD MAJOR BREAST SURGERY PACK. ; SILICONE BREAST IMPLANT.; VALLEYLAB FT10.
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White