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

Catalog Number	8180F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital reported a patient underwent a heart bypass surgery, and during surgery, the electrosurgical patient plates, 8180f were applied.A burn on the back of the right shoulder was observed upon post operative removal of the electrosurgical patient plates.The use of plates were reportedly followed according to the ifu [instructions for use], and the patient is receiving the continuous treatment at the hospital (treatment type not specified) that is a required intervention to prevent impairment, damage and serious injury.
Additional Manufacturer Narrative
H10: an investigation into this lot was performed, and no quality issues were identified.No samples or photos of the actual patient plate used in this case were received although samples of unused products were provided.The unused samples were tested and met specifications.Without a sample of the actual patient plate, it is not possible to perform any tests to determine if the actual patient plate met specifications.The instructions for use (ifu) states to reduce the risk of burns, all instructions should be followed as per the instructions for use provided.The site must be clean, dry and free of hair at application site.The patient plate should not be overloaded with too much current.If the electrosurgical device or active accessory was activated for a longer period of time of time than recommended per the ifu, it is possible this could overload the patient plate with too much current and result in a patient burn.The ifu also states that to reduce the risk of patient burns, the lowest possible power setting should be used; short activation times should be used and if long activation time is necessary to allow for time between activations to allow the tissue under the patient plated to cool; and if the desired surgical effect is not received to 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 PLATE
• Common Device Name: ELECTROSURGICAL RETURN ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION; 3m center, building 275-5w-06; st. paul MN 55144 1000
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 18389801
• Report Number: 2110898-2023-00099
• Device Sequence Number: 4196516
• Product Code: GEI
• UDI-Device Identifier: 50707387563504
• UDI-Public: 50707387563504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2023

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: 01/11/2026
• Device Catalogue Number: 8180F
• Device Lot Number: 2026-01 AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2023
• Initial Report FDA Received Date: 12/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian