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

Model Number	E2516H-GNSB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696); No Code Available (3191)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a caesarian section, the device turned itself "on" with the button on the off" position resulting in burns on the patient's body.There was two 3rd degree burns and 3 2nd degree burns.The 3rd degree burn on right mons pubis and left leg.2nd degree bilateral labia minora inferior to the clitoris.The surgeon removed burnt skin in two 3rd degree burns and placed 3 sutures.They also applied silver sulfadiazine cream.The procedure was delayed for 5-10 minutes.The patient is currently healing well.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The device was plugged into a 40k ohm test box and activated in both the cut and coag mode with satisfactory results.The device plugged into a generator and activated normally.The device was hipot tested with satisfactory results indicating no electrical leakage.The investigation found the device to function normally and within specifications.The instructions for use (ifu) states, confirm proper electrosurgical generator power setting before proceeding with surgery.Use the lowest power setting to achieve the desired surgical effect.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a caesarian section, the device turned itself "on" with the button on the off" position resulting in burns on the patient's body.There was two 3rd degree burns and 3 2nd degree burns.The 3rd degree burn on right mons pubis approximately 2.5cm and left leg 3 cm.2nd degree bilateral labia minora 1 cm inferior to the clitoris.The surgeon removed burnt skin in two 3rd degree burns and placed 3 sutures.They also applied silver sulfadiazine cream.The procedure was delayed for 5-10 minutes.The patient is currently healing well.

• 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: 8429176
• Report Number: 1717344-2019-00353
• Device Sequence Number: 16551266
• Product Code: GEI
• UDI-Device Identifier: 20884524003013
• UDI-Public: 20884524003013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: E2516H-GNSB
• Device Catalogue Number: E2516H-GNSB
• Device Lot Number: 82420148X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 84