SURE LOC XPS ARM POSITIONER
Received Apr 8, 2016 · Event occurred Mar 14, 2016
Report 1043572-2016-00036 · MDR key 5563998
Device
Generic name
Table Accessory
Manufacturer
Steris Corporation - MontgomeryProduct problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE FACILITY STATED THAT ON MULTIPLE OCCASIONS, THE UNIT WAS POSITIONED, AND MINUTES LATER, THE POSITIONER DROPPED APPROXIMATELY ONCE INCH. A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE UNIT, AND IDENTIFIED THE TRIGGER PIN DID NOT SEEM FULLY ENGAGED IN THE UNIT'S LOCKING MECHANISM. THIS WOULD CAUSE THE UNIT TO SLIP TO THE NEXT LOCKING POSITION AS REPORTED BY THE FACILITY. THE UNIT WAS REMOVED FROM SERVICE AND RETURNED TO THE 3RD PARTY MANUFACTURER FOR FURTHER EVALUATION. A REPLACEMENT UNIT HAS SINCE BEEN PROVIDED TO THE USER FACILITY; NO FURTHER ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE FACILITY REPORTED THAT THE SURE LOC ARM POSITIONER DID NOT OPERATE TO SPECIFICATION DURING A PATIENT PROCEDURE. NO INJURY, PROCEDURAL DELAY, OR CANCELLATION WAS REPORTED.