inforMED
MalfunctionHNZ

KATENA

Received Jul 10, 2014 · Event occurred Jun 4, 2014

Report MW5037466 · MDR key 3964825

Device

Generic name

Chopper

Model number

K3-2398

Product problems

  • Component Missing

Patient

88 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

OUTPATIENT IN FOR CATARACT REPAIR. SURGEON USED CHOPPER DURING PROCEDURE AND WHEN THE INSTRUMENT WAS REMOVED, AN 1.5MM METAL TIP WAS MISSING FROM THE INSTRUMENT. INSTRUMENT DID NOT COME IN CONTACT WITH ANY HARD TISSUE OR SURFACES DURING THE PROCEDURE. THIS REQUIRED EXTENSIVE DIRECT VISUALIZATION OF THE AREA AND AN X-RAY TO RULE OUT THE PRESENCE OF A FOREIGN BODY WITHIN THE OCULAR CAVITY.