MAUDE Adverse Event Report: ST. JUDE MEDICAL DISPOSABLE GROUNDING PAD W/CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number RF-DGP-S

Device Problems Insufficient Heating (1287); Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/29/2021

Event Type  Injury  

Event Description

During a radiofrequency ablation procedure, the generator was not able to reach the appropriate temperature and the procedure was then cancelled.In addition, a second degree burn was noted at the grounding pad site after the cancellation.The patient was noted to be hairy at the site of the grounding pad.The patient was treated with comfeel dressing and was noted to be stable.There was no performance issues with the generator or probe and the insufficient heating was due to the improper placement of the grounding pad.

Manufacturer Narrative

One rf disposable grounding pad was received for evaluation.The presence of a hair-like foreign material on the grounding pad, in addition to the reported event of the patient not being shaved, is consistent with placement of the grounding pad over hair.The rf disposable grounding pad instructions for use (ifu) warns ¿avoid placement over scars, bony prominences, prosthesis, hair, or ecg electrodes.Failure to achieve good skin contact by the entire surface of the grounding pad may result in significant electrosurgical burns at the pad location¿.Functional testing was not possible due to the aforementioned damage.The root cause of the patient burn is consistent with incorrect placement of the grounding pad.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 12134357
• MDR Text Key: 260444354
• Report Number: 2182269-2021-00059
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K111576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RF-DGP-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention