THE CUSTOMER DID NOT RETURN THE ENTIRE INVOLVED DEVICE BUT SENT US ONLY THE METAL WIRE HE HAD RECOVERED FROM ITS SURFACE. THE PIECE OF WIRE IS ABOUT 40MM OF LENGTH AND HAS A DIAMETER OF 0,39MM. THE INVESTIGATION REVEALED THAT THE WIRE MUST HAVE BEEN INTRODUCED INADVERTENTLY ONTO THE GEL SURFACE IN THE PRODUCTION MACHINE. THE ONLY CONCEIVABLE SOURCE IS A STEEL BRUSH USED AT A NEARBY PACKAGING MACHINE, ALTHOUGH THE DIAMETER OF ITS STRANDS APPEARS TO DIFFER IN DIAMETER. CORRECTIVE ACTION TO PREVENT RECURRENCE IS BEING DEVELOPED AND WILL BE IMPLEMENTED.
D
Patient 1
ON (B)(6) 2017, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ZIMMER STIMULATION ELECTRODES. DURING A THERAPY SESSION A PATIENT RECEIVED STIMULATION THROUGH A PAIR OF STIMULATION ELECTRODES. DURING THE TREATMENT, THE PATIENT STARTED TO FEEL PAIN. THE THERAPIST RESPONDED IMMEDIATELY, CHECKED THE ELECTRODES AND DISCOVERED AN APPROXIMATELY 40 MM LONG METAL STRAND. NO MEDICAL INTERVENTION WAS NECESSARY. NOR FURTHER DETAILS ON THE PATIENT AND THE PROCEDURE HAVE BEEN DISCLOSED.