InjuryFHM
UNKNOWN TRI STAPLE PRODUCT
Received Feb 25, 2011 · Event occurred Jan 11, 2011
Report 1219930-2011-00150 · MDR key 2010697
Device
Product problems
- Device Operates Differently Than Expected
Patient
65 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
PROCEDURE: THORACIC. ACCORDING TO THE REPORTER: THE PT EXPERIENCED BILATERAL SOFT TISSUE EMPHYSEMA IN CHEST WALL AND NECK. THE SURGEON INDICATED THAT THE DEVICE WAS POSSIBLY RELATED TO THE EVENT. THE EVENT REQUIRED INITIAL OR PROLONGED HOSP STAY.