MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT MACROLYTE DISPERSIVE ELECTRODE; ESU GROUNDING PAD

Catalog Number	400-2100
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	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported event cannot be verified.A two-year lot history review was conducted and found no other similar events reported for this lot number.A dhr review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been 13 complaints regarding 33 devices for this device family and failure mode.During the same time frame 9,235,360 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.000004 per the instructions for use, the user is advised the following; select a well vascularized site in close proximity to the surgical site (anterior arm or thigh is recommended).Avoid placement on bony prominence, skin lesions or folds, tattoos, scars, metal prosthesis or near ecg electrodes and cables.Do not apply where fluid may pool.Always use largest size pad per the patient weight guidelines which can be properly applied to the site: adult products are for use on patients weighing more than 15 kg.Pediatric pads are for use on patients weighing between 5 and 15 kg.Prepare the skin at the application site according to facility protocol.If no protocol exists, clip excess hair at application site, clean and disinfect area to remove oils, lotions, etc., and allow to dry thoroughly.Do not open package until ready to apply pad to skin.Inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.After patient is in the final position, carefully remove the pad from the disposable liner by grasping the liner from the end located away from the cable attachment end of the pad, and slowly peeling the pad from the disposable liner.Avoid excess skin or finger contact with the adhesive or gel surface prior to application.The pad should be applied to the patient with the long side of the pad perpendicular to the direction of current flow from the operative site.Apply the pad firmly to skin, ensuring full adhesion of the pad gel and adhesive, and full pad contact with patient's skin.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that during a leep (loop electrosurgical excision procedure) on approximately (b)(6) 2020 the patient received a possible 3rd degree burn.The burn was noticed after the procedure, it was located under the 400-2100, macrolyte grounding pad.The procedure was approximately 37 minutes long.There were no alarms indicating there was any issue.The pad was attached to a birtcher 4400 - power plus.The skin was not prepped prior to pad placement, (no clipping of hair or cleaned with solutions).The skin was intact prior to pad placement.The pad had full contact with the skin.The pad was placed on the right anterior mid thigh.The burn was treated with ointment and patient is reported as ok.This report is being raised as patient injury due to receiving a 3rd degree burn.

• Brand Name: MACROLYTE DISPERSIVE ELECTRODE
• Common Device Name: ESU GROUNDING PAD
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 10194319
• Report Number: 3007305485-2020-00234
• Device Sequence Number: 2301781
• Product Code: GEI
• UDI-Device Identifier: 20653405006999
• UDI-Public: (01)20653405006999(17)220218(30)100(10)202002194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: 02/18/2022
• Device Catalogue Number: 400-2100
• Device Lot Number: 202002194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/25/2020
• 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: Other