inforMED
MalfunctionHTT

QUADCUT STRAIGHTSHOT

Received Mar 1, 2013 · Event occurred Feb 4, 2013

Report 2994002 · MDR key 2994002

Device

Generic name

Blade, Burr

Model 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.