MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ UNIVERSAL ELECTROSURGICAL PAD; ELECTROSURGICAL RETURN ELECTRODE, SINGLE-USE

Model Number 9135-LP

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Product sample was not returned to 3m for analysis.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the patient plate met specification.3m cannot determine the exact root cause of the alleged injury or whether an electrode was the root cause.A review of complaint trending for this device was completed and no adverse trends were observed.3m will continue to monitor.To reduce the risk of burns, all instructions should be followed as per the instructions for use (ifu).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.3m¿ will continue to monitor.

Event Description

A hospital reported a 64-year-old female allegedly experienced burns with the use of 3m¿ universal electrosurgical pad, 9135-lp.Post operative joint replacement surgery, the first return electrode was reportedly charred/burnt and the patient allegedly experienced 4th degree burns.Medical intervention was reportedly required, type and date are unknown as well as the patient's current status.On 18-nov-2022, the following information was provided to 3m: a standard type of electrode was used in this case.The resistance reportedly became high, and thus could not be energized.Scorching was observed on the opposite of the return sample from the cord.It was noted that the cord was pulled, the return electrode peeled off, therefore, was in contact with the scorched area.It was assessed that there was no problem with the product.The gel of the returned sample was uniform, and electricity could be supplied at first.Conmed's electrosurgical unit can be used as a split type, therefore, this case may not have occurred if a split type had been used.This case was reportedly due to user error, although the relationship between the burn and the 3m¿ universal electrosurgical pads 9135-lp cannot be excluded.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PAD
• Type of Device: ELECTROSURGICAL RETURN ELECTRODE, SINGLE-USE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 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: 15958051
• MDR Text Key: 305239809
• Report Number: 2110898-2022-00123
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 50707387580730
• UDI-Public: 50707387580730
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 9135-LP
• Device Catalogue Number: 9135-LP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian