2.75 HEX COATED BLADE NSB
Received Oct 29, 2010 · Event occurred Sep 9, 2010
Report 1717344-2010-00744 · MDR key 1888741
Device
Generic name
Electrosurgical Accessory
Manufacturer
Covidien Lp (valleylab)Catalog number
E1450XNSB
Lot number
UNK
Product problems
- Fire
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THERE WAS A FLAME ON THE TIP OF THE ELECTRODE. THE SITE TESTED THE PENCIL AND ELECTRODE AT THEIR SITE, BUT COULD NOT REPLICATE THE EVENT. THE GENERATOR, THE SITE IS USING IS UNK. THE PENCIL TYPE IS ALSO UNK AT THIS TIME. THERE WAS NO PT INJURY.