inforMED
MalfunctionKKX

MITAKA OPERATIVE MICROSCOPE STERILE DRAPE

Received Jul 21, 2026 · Event occurred Jun 10, 2026

Report 25893133 · MDR key 25893133

Device

Generic name

Drape, Surgical

Manufacturer

Mitaka Usa, Inc.

Catalog number

MU5153

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE MIKITA MICROSCOPE WAS TEMPORARILY BACKED FROM STERILE FIELD. SHORTLY AFTER PRIOR TO CLOSING IT WAS FOUND THAT THERE WAS A PIECE OF PLASTIC OR GLASS. UPON EXAMINATION OFF THE STERILE FIELD, THE PIECE OF PLASTIC HAD COME OFF/CRACKED FROM THE MICROSCOPE DRAPE. UPON EXAMINATION IT APPEARED THE PIECE WAS STILL STERILE WAS THERE IS A GAP BETWEEN THE LENS DRAPE AND THE ACTUAL LENS OF MICROSCOPE ON THE INSIDE. BLUE RING OF LENS DRAPE STILL INTACT AND ATTACHED.