inforMED
MalfunctionGZT

BLACK BELT ADVANCED CERVICAL RETRACTOR SYSTEM

Received Dec 17, 2024 · Event occurred Nov 19, 2024

Report 20952016 · MDR key 20952016

Device

Generic name

Retractor, Self-retaining, For Neurosurgery

Manufacturer

Koros Usa, Inc.

Model number

7320

Catalog number

7320

Patient

62 YR · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING A LUMBAR LAMINECTOMY, THE BLACKBELT RETRACTOR WAS USED. ON REMOVAL OF THE RETRACTOR, THE PHYSICIAN SAW THE SCREW FALL OUT ONTO THE DRAPE AND RETRIEVED IT. TO BE SURE NO ITEMS FROM THE RETRACTOR WERE RETAINED IN THE PATIENT, X-RAYS WERE PERFORMED AND NO FOREIGN BODY WERE SEEN. THE RETRACTOR WAS SENT TO CENTRAL STERILE PROCESSING DEPARTMENT FOR CLEANING AND TO BE SENT OUT FOR REPAIR. NO OTHER RETRACTOR WAS NEEDED DURING THE CASE. THIS OCCURRED AT THE END OF THE CASE, NO DELAY AS RADIOLOGY WAS PRESENT IN THE OPERATING ROOM FOR THE CASE.