inforMED
InjuryBXB

OPTIFLEX 3

Received May 6, 2026 · Event occurred May 2, 2026

Report MW5187813 · MDR key 25103196

Device

Generic name

Exerciser, Powered

Model number

2090

Patient

10 YR · Female

  • Pain

Narrative

Description of Event or Problem

MY DAUGHTER, WHO IS 10 YEARS OLD WAS USING THE KNEE CONTINUOUS PASSIVE MOTION DEVICE (OPTIFLEX 3 KNEE CONTINUOUS PASSIVE MOTION, RENTED FROM NEW ENGLAND SURGICAL INC.) SHE WAS SITTING WHILE USING IT WITH HER GOOD LEG CROSSED AND HER FOOT INSIDE THE MACHINE. THIS WAS COMFORTABLE UNTIL THE MACHINE REACHED THE EXTREME OF EXTENSION, WHEN THE SPACE FOR HER CONTRALATERAL FOOT UNDER THE MACHINE BECAME SMALLER UNTIL IT WAS TRAPPED AS THE MACHINE CONTINUED TO EXTEND THE POSTOPERATIVE LEG. THIS BECAME PAINFUL AND MIGHT HAVE BROKEN HER ANKLE IF SHE HAD NOT STOPPED THE MACHINE PROMPTLY. THERE ARE NO GUARDS OR WARNINGS AT THE SIDE OF THE MACHINE TO PREVENT SOMEONE WITH SMALLISH FEET AND ANKLES LIKE MY DAUGHTER FROM INSERTING THEIR FOOT OR ANKLE UNDER THE MACHINE AND BECOMING TRAPPED IN THIS WAY. A YOUNGER CHILD, OR A MORE PANICKY CHILD MIGHT NOT HAVE STOPPED THE MACHINE IN TIME AND HAD A MUCH MORE SEVERE OUTCOME.