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

Model Number	E2530-28
Medical Device Problem Codes	Melted (1385); Flare or Flash (2942)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/18/2018
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, intra-operatively, the exposed tip of the device melted and it burned the patient.This event caused a temporary injury to the patient.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.From the provided information, it is unknown if the device has or has not been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.No product was shown in the picture, it could not determine if the product met specification.The picture showed the label on the package lid stock.No picture of the electrode was attached to the file.The reported condition was not confirmed.The investigation found no picture of the electrode was attached to the file.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during thoracotomy, the exposed tip of the device melted and as the incision was retracted, a second degree burn came from an arc on the hand piece at patient's flank are, the device was not resting on skin.Medication of bacitracin was applied after the procedure was over.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7488284
• Report Number: 1717344-2018-00634
• Device Sequence Number: 16631525
• Product Code: GEI
• UDI-Device Identifier: 10884524000459
• UDI-Public: 10884524000459
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K926481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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 Expiration Date: 05/01/2022
• Device Model Number: E2530-28
• Device Catalogue Number: E2530-28
• Device Lot Number: 71130127X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 04/25/2018; 08/08/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/04/2018; 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1