LEG HOLDER
Received Apr 9, 2026 · Event occurred Mar 16, 2026
Report 8010652-2026-0000034 · MDR key 24825762
Device
Product problems
- Positioning Failure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR LEG HOLDER. AS IT WAS STATED, THE MOUNTING COMPONENT RESPONSIBLE FOR TRANSFERRING THE MOTION AND ENABLING POSITIONAL OF DEVICE ADJUSTMENT FAILED. THE INCIDENT OCCURRED DURING PREPARATION FOR A SURGICAL PROCEDURE AND PATIENT WAS ALREADY ON THE OPERATING TABLE AT THE TIME OF THE EVENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE LOSS OF THE PRODUCT¿S ESSENTIAL PERFORMANCE AND THE RISK OF UNINTENDED MOVEMENT OF THE LEG HOLDER, WAS TO REOCCUR.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1 INITIAL REPORTER: (B)(6). E1 EVENT SITE NAME: (B)(6).