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

Model Number	E2515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/11/2018
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, the device button was not functioning well.When the doctor pressed it, it would start to burn his finger.There was no patient involvement.No further information available.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.It came with an electrode.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Visual inspection found no damage to the device or the associated electrode that was returned with pencil.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 passed hipot testing, showing that there were no unexpected electrical leakages.The investigation did not identify any defects with the pencil that could have contributed to the reported event.The investigation found the device to function normally and within specifications.The instruction 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.

• 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: 8083058
• Report Number: 1717344-2018-01507
• Device Sequence Number: 1598416
• Product Code: GEI
• UDI-Device Identifier: 10884524000497
• UDI-Public: 10884524000497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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 Model Number: E2515
• Device Catalogue Number: E2515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/18/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1