QUADCUT STRAIGHTSHOT
Received Mar 1, 2013 · Event occurred Feb 4, 2013
Report 2994002 · MDR key 2994002
Device
Generic name
Blade, Burr
Manufacturer
Medtronic Xomed, IncModel number
*Catalog number
1884380HR
Lot number
0206266062
Product problems
- Break
Patient
56 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
METAL PORTION BROKE DURING THE PROCEDURE UNDER NORMAL USE. QUESTION IF IT MAY HAVE BEEN CRACKED PRIOR TO USE. NO PATIENT HARM OR CHANGE IN PLAN OF CARE. NO ADVERSE EFFECTS ON PATIENT OR BLOOD LOSS. PROCEDURE COMPLETED AS PLANNED.======================MANUFACTURER RESPONSE FOR MICRODEBRIDING ROTATING BLADE, QUADCUT BLADE, 4.3 MM (PER SITE REPORTER).======================WE PLAN TO RETURN TO THEM FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT AND RIGHT SPHENOETHMOIDECTOMY WITH REMOVAL OF POLYPS; LEFT AND RIGHT MAXILLARY ANTROSTOMY WITH REMOVAL OF POLYPS FOR CHRONIC POLYPOID RHINOSINUSITIS.