MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) DISPOSABLE GROUNDING PAD W/CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number RF-DGP-S

Device Problems Grounding Malfunction (1271); Overheating of Device (1437)

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

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Further information requested but not yet received.

Event Description

During the procedure, the patient experienced a grounding pad burn with reddened skin and blisters.It was noted that the patient was hairy, and the area was not shaved prior to placement of the grounding pad.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.During processing of this incident, attempts were made to obtain complete patient information.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15735451
• MDR Text Key: 303080632
• Report Number: 2182269-2022-00054
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 05415067023629
• UDI-Public: 05415067023629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: RF-DGP-S
• Device Catalogue Number: RF-DGP-S
• Device Lot Number: 20220315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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