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

Model Number	E2504H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/01/2018
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 loop electrosurgical excision procedure(leep), the nurse plugged the cautery pencil into generator without any issues or error message.Another brand of electrode was inserted into the pencil.When the physician activated the cautery unit via foot pedal the filament on the electrode snapped while attempting to excise tissue from the patient.The broken electrode was discarded and new electrode was attached to the pencil.The issue persisted.A third electrode was brought into the room and attached to the pencil.Staff observed, without using the device on the patient when the foot pedal was used to activate the device the electrode visibly overheated and snapped.A new cautery pencil was brought into the room and new electrode was attached and there were no further issues occurred.

• 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: 8091964
• Report Number: 1717344-2018-01520
• Device Sequence Number: 16508604
• Product Code: GEI
• UDI-Device Identifier: 10884524001616
• UDI-Public: 10884524001616
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K791639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 02/21/2022
• Device Model Number: E2504H
• Device Catalogue Number: E2504H
• Device Lot Number: 70430106X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR