MAUDE Adverse Event Report: 3M HEALTH CARE 3M UNIVERSAL ELECTROSURGICAL PAD; GROUNDING PAD

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: not available, weight: not available, ethnicity: not available, race: not available.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 a patient plate was the root cause.To reduce the risk of burns, all instructions should be followed as per the instructions for use (ifu).The complaint description stated betadine was used on the abdomen.The instructions for use states, to reduce the risk of burns the site must be clean, dry and free of hair and to remove hair at application site.The ifu also states to avoid placement over surgical prep solutions containing iodine.The complaint description also stated possible concerns with the generator or with the coagulation device.Without additional information, it is not possible to determine whether a malfunction of the generator or the coagulation device could have contributed to the alleged injury.Currently, it is not possible to tell if any of these factors are the root cause of the alleged injury.Two-year trend chart for all patient plates with the same global sales code, identified failure and cause codes does not indicate an adverse trend.
Event or Problem Description
A hospital reported a female (b)(6)-year-old patient developed a third degree burn from 3m¿ 8180f electrosurgical plate.Patient was undergoing a laparoscopic hysterectomy and was grounded on her upper leg.Surgical site (abdomen) was cleansed with isobetadine.Her leg was not clipped or shaved prior to applying the plate.After thirty seconds into the surgery they heard a cracking sound.Procedure was stopped, plate was removed, and surgeon observed a third-degree burn.Size of burn was not reported.The skin was immediately rinsed with sodium chloride 0.9%.A plastic surgeon was consulted; recommending flaminal hydro at time of injury.Medical intervention reported included a skin graft.Monopolar was used, cut and coagulation was 70.

• Brand Name: 3M UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 10782797
• Report Number: 2110898-2020-00056
• Device Sequence Number: 4246334
• Product Code: GEI
• UDI-Device Identifier: 50707387563504
• UDI-Public: 50707387563504
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: 12/26/2022
• Device Model Number: N/A
• Device Catalogue Number: 8180F
• Device Lot Number: 2022-12RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 46 YR