MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E7506-
Medical Device Problem Codes	Difficult to Remove (1528); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Burn(s) (1757); No Known Impact Or Consequence To Patient (2692); Partial thickness (Second Degree) Burn (2694)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after an atrial fibrillation ablation, a patient found to have grounding pad site burn.It was noted that the integrated precision lab did not use a fluoroscopy.Also noted that the customer was using a flexibility catheter, 3.5 mm irrigated tip.The returned patch was placed 1 inch right of the spine at the apex of scapula.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after an atrial fibrillation ablation, a patient had found to have grounding pad site second degree burn.Topical ointment was applied on the burn site.The return patch was placed 1 inch right of the spine at the apex of scapula.It was noted that the integrated precision lab did not use a fluoroscopy.Also noted that the customer was using a flexibility catheter, 3.5 mm irrigated tip with intracardiac echocardiography the entire procedure.Generator setting of 30-50 w.No further information available at this time.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7767895
• Report Number: 1717344-2018-01054
• Device Sequence Number: 1319943
• Product Code: GEI
• UDI-Device Identifier: 10884524000985
• UDI-Public: 10884524000985
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K822572
• 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,Followup,Followup
• Report Date (Section B): 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E7506-
• Device Catalogue Number: E7506-
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 08/08/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/06/2018; 10/02/2018
• 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