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

Model Number	E1551-6
Medical Device Problem Codes	Arcing (2583); Flare or Flash (2942)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	07/13/2018
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, intraoperatively, the electrode's middle part of the tip was sparking on the stomach.There was a small burn on the stomach wall and the burn was treated by suturing the damaged tissue.New device was opened to complete the procedure.
Additional Manufacturer Narrative
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 drive; boulder CO 80301
• MDR Report Key: 7732767
• Report Number: 1717344-2018-00999
• Device Sequence Number: 2643949
• Product Code: GEI
• UDI-Device Identifier: 10884521175624
• UDI-Public: 10884521175624
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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 Model Number: E1551-6
• Device Catalogue Number: E1551-6
• Device Lot Number: 72720200X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1