MAUDE Adverse Event Report: BAISHENG MEDICAL CO., LTD AVANTE ASG 350 ELECTROSURGICAL GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number ASG 350

Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)

Patient Problems Scar Tissue (2060); Full thickness (Third Degree) Burn (2696)

Event Date 07/28/2022

Event Type  Injury  

Event Description

As per the clinical director, during a breast lift procedure, a 42 year old female patient received 3rd degree burns from this unit on their right anterior thigh.The grounding pads included in the purchase were used on the patients thighs.The practice advised the patient will need scar revision/possible skin graft.There's possible nerve damage.They prescribed silvadene cream for the patient as they still have the 3rd degree burn on their right thigh.The doctor doesn't want to return the unit.The clinical director at the office advised this was their second time using the unit but the first time it happened.This item was shipped directly to the customer since its a dropshipped order, please reference po# (b)(4).(b)(6) in sales at avante advised that last friday afternoon (b)(6)2022 they were notified by (b)(6) telesales rep) about this incident and their legal and risk management teams were also made aware.After avante's investigation, it was determined that customer misuse led to the patient injury by using two grounding pads during the procedure.This shut off the grounding safety alarm so the surgeons and staff were not given an audible alarm regarding the patient being ungrounded.Avante reached out to our insurance company to correspond with the customer for resolution.The customer stopped responding to correspondence.The customer did not return this unit for inspection.

• Brand Name: AVANTE ASG 350 ELECTROSURGICAL GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BAISHENG MEDICAL CO., LTD; jaingmen, guangdong 52910 0 CN; CH 529100 CN
• MDR Report Key: 17003134
• MDR Text Key: 315939428
• Report Number: MW5117840
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASG 350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female