MAUDE Adverse Event Report: COVIDIEN CLEANCOAT LAPAROSCOPIC WIRE L HO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NR10734 REV A
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having surgery laparoscopically with a bovie and l hook electrode.The l-hook electrode sparked and caused a small burn under the trocar.Fda safety report id# (b)(4).

• Brand Name: CLEANCOAT LAPAROSCOPIC WIRE L HO
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10086681
• Report Number: MW5094651
• Device Sequence Number: 19489488
• Product Code: GEI
• UDI-Device Identifier: 10884521550803
• UDI-Public: 10884521550803
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 06/30/2024
• Device Model Number: NR10734 REV A
• Device Catalogue Number: 1904170X
• Device Lot Number: 1904170X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 69