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

Model Number	E7512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/26/2018
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, pen was on the generator with a brand new return electrode pad.When the surgery was completed and removed the clamps holding the huck towels, it was found that the metal clamps had burned the patient's skin, leaving two round burn marks at the inner thigh, both 1cm in diameter each, black spots that turned white.It was diagnosed as second degree burn and was treated with silver sulfadiazine.The electrode was new but the pen was not.The device showed that the return pad was grounded at all times.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found that the incident sample was not sent by the customer.An unused device (with the same lot #) was received.The reported condition was not confirmed.The investigation did not identify any defects with the unused pad that was sent.Visual inspection found the pad to have been assembled correctly.The pad passed continuity testing.The pad passed erit testing.The investigation did not identify any defects that would have contributed to the reported failure.The instructions for use (ifu) states, select a well vascularized, convex area win close proximity to the surgical site.Shave, clean and dry application site as needed.Lightly touch the surface of the return electrode to insure that the conductive adhesive is moist.Pull the return electrode taut and apply it to the patient on the bias for better adhesion.Apply finger pressure to massage the entire surface of the return electrode to ensure secure contact with the patient's skin.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: 8107987
• Report Number: 1717344-2018-01550
• Device Sequence Number: 1827638
• Product Code: GEI
• UDI-Device Identifier: 10884524001067
• UDI-Public: 10884524001067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K994428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 09/17/2020
• Device Model Number: E7512
• Device Catalogue Number: E7512
• Device Lot Number: 82610131X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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: Other
• Patient Age: 80 MO
• Patient Weight: 28