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

Model Number	E7506-
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.The product in the picture appeared to meet specification.The picture showed the pad with a clump of fur stuck to the gel.The gel was intact and without voids.The reported condition was not confirmed.The investigation could not identify any defects with the pad that would have contributed to the reported event.The investigation could not determine the root cause of the customer's report.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.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the unit's output was too high.The veterinarian was burnt.The photo showed that the burn was from the pad and in the animal not in the veterinarian.

• 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: 10060186
• Report Number: 1717344-2020-00519
• Device Sequence Number: 11656098
• Product Code: GEI
• UDI-Device Identifier: 20884524000982
• UDI-Public: 20884524000982
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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: 01/03/2022
• Device Model Number: E7506-
• Device Catalogue Number: E7506-
• Device Lot Number: 00020018X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1