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

Model Number	E2450HNSB
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
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, after surgery for orthopedic fracture of distal end of femur, they found a part of cushion and cover cloth placed under the patient's leg was burnt.They put a triangular metal supporter on the black cushion and the patient placed the right leg on the supporter with bending knee to upward direction.They placed cover cloths on the cushion and they found all the same positions were burnt.As per nurse's consideration, the pencil went between the cushion and the metal supporter and according to the report, had activated accidentally due to the weight of leg.There was no patient injury.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9437475
• Report Number: 1717344-2019-01600
• Device Sequence Number: 11351184
• Product Code: GEI
• UDI-Device Identifier: 10884524002231
• UDI-Public: 10884524002231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• 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: E2450HNSB
• Device Catalogue Number: E2450HNSB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VLFT10GEN(SERIAL: UNKNOWN)