inforMED

STERIS OT-1100 FRACTURE TABLE

Received Jan 16, 2018

Report MW5074597 · MDR key 7199595

Device

Generic name

Table, Surgical

Manufacturer

Steris Corp.

Product problems

  • Break
  • Self-Activation or Keying
  • Unintended Movement

Patient

Not reported

  • No Information
  • No Information

Narrative

Description of Event or Problem

AN ORTHOPEDIC SURGEON WAS UTILIZING A STERIS OT-1100 FRACTURE TABLE DURING A SURGICAL PROCEDURE. PRIOR TO COMMENCING THE SURGERY, THE FRACTURE TABLE HAD BEEN SET TO THE HEIGHT AND ANGLE REQUESTED BY THE SURGEON. DURING THE SURGERY, THE FRACTURE TABLE TILTED DOWNWARD AT THE LOWER END OF THE TABLE. NONE OF THE SURGERY PERSONNEL WITNESSED THE MOVEMENT OF THE TABLE. ADJUSTMENTS TO THE HEIGHT AND POSITION OF THE TABLE ARE MADE USING THE HANDHELD CONTROL WHICH IS ATTACHED TO THE TABLE VIA CORD. NONE OF THE PERSONNEL WERE OPERATING THE HANDHELD CONTROL AT THE TIME OF THE INCIDENT. THE DEVICE MANUFACTURER WAS CONTACTED AND SENT A SERVICE TECHNICIAN TO INSPECT THE FRACTURE TABLE. AFTER A THOROUGH INSPECTION, NO ISSUES WERE IDENTIFIED WHICH WOULD HAVE RESULTED IN MOVEMENT OF THE TABLE (I.E. HYDRAULIC LEAK). THE SERVICE TECHNICIAN COULD NOT GET THE FRACTURE TABLE TO REPEAT THE INCIDENT DURING HIS INSPECTION. IT WAS NOTED THAT THE HANDHELD CONTROL SHOWED SOME DAMAGE. THE HANDHELD REMOTE WAS REPLACED PRIOR TO PLACING THE FRACTURE TABLE BACK IN SERVICE.