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

Model Number	VL2610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/14/2018
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, during the procedure, the patient had burns in various parts of the body specifically at the arms, legs and foot.Apparently, there was leakage of energy and the burns occurred due to the inadequate substance used for asepsis with alcoholic content.It was identified that there was an automatic activation when the pedal was connected to the equipment, as there was poor contact in the pedal cable.
Additional Manufacturer Narrative
Additional information:evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.The product was not included in the pictures provided.The picture showed burns on a patient.Without the product, a detailed investigation could not be performed.The file will be closed as unconfirmed at this time.If additional information is obtained, or the product is returned, we will re-open this investigation.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 drive; boulder CO 80301
• MDR Report Key: 8034716
• Report Number: 1717344-2018-01432
• Device Sequence Number: 1435413
• Product Code: GEI
• UDI-Device Identifier: 10884521196636
• UDI-Public: 10884521196636
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K982743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 01/31/2022
• Device Model Number: VL2610
• Device Catalogue Number: VL2610
• Device Lot Number: 1611095X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR