MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ ELECTROSURGICAL PATIENT PLATES; ELECTROSURGICAL RETURN ELECTRODE

Model Number	8180F
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 75-year-old male allegedly experienced a left lateral mid-thigh 6x4 cm 2nd degree burn with the use of the 3m¿ electrosurgical patient plates 8180f, lot: 202510mv, and subsequently underwent debridement of the necrotic tissue.
Additional Manufacturer Narrative
E2 - e3: it is unknown if the reporter is a health professional.H10: product sample was not returned to 3m for analysis; however, review of manufacturing records confirmed the released lot met all specifications.Without a sample, it is not possible to perform any tests to determine if the plate met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether the 3m¿ electrosurgical patient plates were the root cause.To reduce the risk of burns, all instructions should be followed as per the instructions for use (ifu).Instructions for use state, to reduce the risk of burns and pressure necroses: do not overload the patient plate with too much current.Do not activate the electrosurgical device or active accessory for more than 60 seconds in any 2-minute period, as this will overload the patient plate with current and may result in a patient burn.Use the lowest possible power setting.Use short activation times.If long activation is necessary, allow time between activations to allow the tissue under patient plate to cool.If you do not receive the desired surgical effect, stop, and verify the correct distention/irrigation solution and good patient plate contact before proceeding with electrosurgery or increasing the power setting.

• Brand Name: 3M¿ ELECTROSURGICAL PATIENT PLATES
• Common Device Name: ELECTROSURGICAL RETURN ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul 55144 1000
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 east meigs st.; valley NE 68064
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17064063
• Report Number: 2110898-2023-00046
• Device Sequence Number: 6129872
• Product Code: GEI
• UDI-Device Identifier: 10707387802919
• UDI-Public: 10707387802919
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K833364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2025
• Device Model Number: 8180F
• Device Catalogue Number: 8180F
• Device Lot Number: 202510MV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male