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

Model Number	E2516H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
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 a procedure, at 1520, while the resident was retracting the tissue and the surgeon was utilizing the pencil, a non-medtronic gauze in the resident's hand heated up, smoked and caught on fire.The resident pulled the non-medtronic gauze away from the patient and noticed that it was indeed smoking.He brought the non-medtronic gauze further from the drapes towards the foot of the bed and informed the circulation nurse.The nurse told the resident to drop the flaming non-medtronic gauze on a clear area on the floor.The nurse scrubbed out to put out the fire using the saline on her field with an asepto bulb syringe.After informing the resource nurse, the patient was assessed for burns.The attending, resident and nurse checked the skin before applying dressings but the skin was free from any injury or burns at 1607.The return electrode management (rem) pad was removed at 1613 a nd the site was clear and intact.It was noted that the surgeon and resident were utilizing the pencil properly and it was not in direct contact with the non-medtronic sponge that caught fire.The resident was holding the non-medtronic gauze with the same hand that was used to hold the retractor.The pencil was in use near the retractor which became a possible conductor of current or spark that led to the incident.

• 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: 9436973
• Report Number: 1717344-2019-01599
• Device Sequence Number: 14485733
• Product Code: GEI
• UDI-Device Identifier: 10884524000053
• UDI-Public: 10884524000053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• 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): 12/09/2019

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: E2516H
• Device Catalogue Number: E2516H
• 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: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR