MalfunctionJOS
EDGE INSLTD BLADE W/SLV 2.75
Received Jul 14, 2015
Report 1717344-2015-00503 · MDR key 4912203
Device
Product problems
- Component Falling
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING A VATS PROCEDURE, THE ELECTRODE FELL OUT OF THE PENCIL. IT WAS RETRIEVED FROM THE SURGICAL SITE WITHOUT INJURY TO THE PATIENT. THE DEVICE WAS DISCARDED.
Additional Manufacturer Narrative
(B)(4). THE INCIDENT DEVICE WAS DISCARDED BY THE SITE. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.