MalfunctionJOS
EDGE INSLTD BLADE W/SLV 2.75
Received May 26, 2010 · Event occurred May 5, 2010
Report 1717344-2010-00357 · MDR key 1709586
Device
Generic name
Electrosurgical Accessory
Manufacturer
Covidien Lp (valleylab)Catalog number
E1455B
Lot number
163930
Product problems
- Fire
- Smoking
- Arcing
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B) (4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE SURGEON REPORTED THAT THE DEVICE ARCED, SAW A PUFF AND A FLAME AT THE SURGICAL SITE. O2 WAS IN USE BUT THE FLOW RATE WAS UNK. THERE WAS NO PT INJURY.