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

Model Number	E7510-25DB
Health Effect - Clinical Codes	Burn(s) (1757); Skin Irritation (2076); Burn, Thermal (2530)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, an irritation of the skin on the right external femur of patient was identified postoperatively in the postanaesthesia care unit.The hypospadias operation was performed in supine position with the device and a monopolar switch pencil with needle electrode.The patient return electrode was glued at the back.During the operation there were no abnormalities.The test protocols were added and no malfunctions were detected on the generator.A photo submitted showing the skin at the thigh part with skin burn.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, an irritation of the skin on the right external femur of patient was identified postoperatively in the postanaesthesia care unit.The hypospadias operation was performed in supine position with the device and a monopolar switch pencil with needle electrode.The patient return electrode was glued at the back of patient.During the operation there were no abnormalities noted.The test protocols were added and no malfunctions were detected on the generator.It has been subsequently reported that the child is suffering from neurodermatitis and it is an overly sensitive reaction to the disinfectant.A photo submitted showing the skin at the thigh part with skin burn.
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.

• 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: 7718280
• Report Number: 1717344-2018-00968
• Device Sequence Number: 16369661
• Product Code: GEI
• UDI-Device Identifier: 10884524001050
• UDI-Public: 10884524001050
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E7510-25DB
• Device Catalogue Number: E7510-25DB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/28/2018; 08/08/2018; 10/22/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/07/2018; 10/03/2018; 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 MO
• Patient Weight: 11