inforMED
InjuryBWN

BARIATRIC SURGICAL TABLE

Received Apr 6, 2023

Report MW5116424 · MDR key 16700654

Device

Generic name

Table And Attachments, Operating-room

Manufacturer

Steris Corporation

Model number

5085

Product problems

  • Unintended Movement

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

FOUR (4) DIFFERENT STERIS 5085 BARIATRIC SURGICAL TABLES ALLOWED THE TABLE TOP TO MOVE IN AN UNCONTROLLED MANNER. IN ONE INCIDENT THE ROBOT WAS ABOUT TO BE CONNECTED TO THE PATIENT WHEN THIS OCCURRED. IF THE ROBOT HAD BEEN IN USE, SERIOUS INJURY OR DEATH COULD HAVE OCCURRED. THE FAILURE POINT WAS THE EXACT SAME COMPONENT (TABLE SLIDE DRIVE ASSY - 413724070). REFERENCE REPORT MW5116421, MW5116423, MW5116422.