MAUDE Adverse Event Report: CONMED UTICA THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 7-382

Device Problem Excessive Heating (4030)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Skin Discoloration (2074)

Event Date 08/18/2022

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 7-382, thermogard plus abc dual dispersive electrode was being used on 18aug22 during a robotic total laparoscopic hysterectomy with bilateral salpingo-oophorectomy procedure when it was reported ¿looked like a pad site bruise/ discoloration.¿ further assessment questioning found that ¿the nurse could not diagnose the degree of burn, but presumed it was a first degree burn, there was no treatment, and was not caused by an allergic reaction.The user diagnosed the site by determining the bruise/discoloration was not there prior to the procedure and corresponded with the location of the pad." the procedure was completed with no report of delay.It was also reported that the physician examined patient the next day and the discoloration/bruise was no longer apparent.The patient is presumed stable and was discharged.There was no reported medical intervention, or hospitalization for the patient.The device 60-7550-120, system 7550, 120v was also used in correlation with the thermogard pads and will be listed as a concomitant device.This report is being raised on the basis of injury due to unknown degree of burn.

Event Description

The sales representative reported on behalf of the customer that the 7-382, thermogard plus abc dual dispersive electrode was being used on (b)(6) 2022 during a robotic total laparoscopic hysterectomy with bilateral salpingo-oophorectomy procedure when it was reported ¿looked like a pad site bruise/ discoloration.¿ further assessment questioning found that ¿the nurse could not diagnose the degree of burn, but presumed it was a first degree burn, there was no treatment, and was not caused by an allergic reaction.The user diagnosed the site by determining the bruise/discoloration was not there prior to the procedure and corresponded with the location of the pad." the procedure was completed with no report of delay.It was also reported that the physician examined patient the next day and the discoloration/bruise was no longer apparent.The patient is presumed stable and was discharged.There was no reported medical intervention, or hospitalization for the patient.The device 60-7550-120, system 7550, 120v was also used in correlation with the thermogard pads and will be listed as a concomitant device.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device has not been returned for evaluation to date and no photographic evidence was provided therefore the reported event could not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15432688
• MDR Text Key: 300025803
• Report Number: 1320894-2022-00193
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405013741
• UDI-Public: (01)30653405013741(17)230518(10)202105181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Catalogue Number: 7-382
• Device Lot Number: 202105181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 60-7550-120, SYSTEM 7550, 120V; 60-7550-120, SYSTEM 7550, 120V
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic