VOLISTA STANDOP

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. AS IT WAS STATED ONE FIXING SCREW WAS LOOSE. LAST MAINTENANCE WAS PERFORMED 1 YEAR AGO BY GETINGE. THERE WAS NO INJURY REPORTED.

Additional Manufacturer Narrative

THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHTS DID NOT MEET ITS SPECIFICATION, SINCE LOOSENED SUSPENSION SCREWS COULD BE CONSIDERED AS TECHNICAL DEFICIENCIES, AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICES WERE OR WERE NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ACCORDING TO SUBJECT MATTER EXPERT AT MANUFACTURER¿S, THE MOST PROBABLE ROOT CAUSE OF SUSPENSION FIXING SCREWS LOOSENED WOULD BE AN INCORRECT INSTALLATION/MAINTENANCE. IN CASE OF LOOSENING, THE PROBABLE CAUSES OF LOOSENING CORRESPOND TO AN IMPROPER INITIAL TIGHTENING DURING THE INSTALLATION OR A MAINTENANCE NOT IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM MENTIONS: TO CHECK THE SUSPENSION FIXING SCREWS. IT IS ALSO INDICATED TO NOT RETIGHTEN THE SCREWS DURING MAINTENANCE. IF SCREWS APPEAR LOOSENED REPLACE THEM. TO REPLACE THE 6 FIXING SCREWS EVERY 6 YEARS. IN APRIL 2019 GETINGE TRANSMITTED THE SERVICE BULLETIN 98 ON GETINGE ONLINE REMINDING TO CARRY OUT PREVENTIVE MAINTENANCE AND WEARING PARTS REPLACEMENT TO ENSURE THE DEVICE SAFETY. THE SERVICE BULLETIN 98 MENTIONS TO REPLACE THE SUSPENSION FIXING SCREWS EVERY 6 YEARS DURING THE PREVENTIVE MAINTENANCE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.