MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GROUND PAD TDS ADULT END CONN.; GEI - ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 400-2100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Skin Tears (2516)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of the reported issue of the patient burn is confirmed.The device in question, used in the procedure, is not available for evaluation by conmed.The device will not be returned for evaluation however photographic evidence has been provided that exhibits the reported claim.At this time the root cause of the event cannot be determined, however based on the photos provided, the likely cause of this issue is the device was misused as the pad site was not properly prepped.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 17 complaints, regarding 18 devices, for this device family and failure mode.During this same time frame 8,602,460 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.000002.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user to 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.To remove the pad, gently support the skin surface and slowly peel away the pad.Rapid removal may cause skin damage.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of their customer, the distributor in (b)(6) reported issues with the 400-2100, ground pad tds adult, lot 202102024, that clinica nuestra cartagena recently experienced on (b)(6) 2021.The only information received was that patient who, at the beginning of the procedure, places an electroplate on the skin on the right thigh while working, immediately there is slight burns produced by it.We proceed to remove plaque and cure the patient.It is noted the procedure was successfully completed by using other equipment and involved a (b)(6) year old.Pictures provided by the distributor show there is a blackened substance on the pad and there is hair attached to the pad as well.It is not clear if the images show a 2nd or 3rd degree burn to the patients thigh area and / or if the skin was also pulled off when the pad was removed.Clarification was received that notes the patient was disinfected and dressed, the surgical site was incised, and when the surgeon activated the electrode, they heard a noise and smell as when something was burning and immediately checked the site of the pad and detected the burn.When the area was checked, the hair was detached with part of the skin.The area was treated with a local treatment, with a topical cream.The patient is currently recovered, the burn has resolved.The pad was discarded per pandemic protocol.The additional information received does not impact the reporting determination.This report is being raised on the basis of injury as there is a visible wound / damage to the patients thigh.

• Brand Name: GROUND PAD TDS ADULT END CONN.
• Type of Device: GEI - ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12413491
• MDR Text Key: 269521839
• Report Number: 3007305485-2021-00367
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405006996
• UDI-Public: (01)30653405006996(17)230202(10)202102024
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2021

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 Expiration Date: 02/02/2023
• Device Model Number: 400-2100
• Device Catalogue Number: 400-2100
• Device Lot Number: 202102024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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): Other
• Patient Age: 50 YR