LUCEA 10/40

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 10/40. IT WAS STATED THE SAFETY SCREW WAS BROKEN RESULTING IN RISK OF HEADLIGHT'S DETACHMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY IN CASE OF REOCCURRENCE. THE DEVICE HAS BEEN REPAIRED BY REPLACEMENT OF HANDLE INTERFACE WITH FORK - LUCEA 40 (ARD368605998) AND RETURNED TO USE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS NOT KNOWN IF THE CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ACCORDING TO THE ANALYSIS BY SUBJECT MATTE EXPERT, IT WAS DETECTED A BROKEN SCREW ON A LUCEA 40 EXAMINATION LIGHT MANUFACTURED IN FEB 2012. ACCORDING TO THE INFORMATION PROVIDED THE SCREW INVOLVED IS INCLUDED IN THE KIT ARD369051555, THIS SCREW IS LOCATED ON THE MECHANICAL CONNECTION BETWEEN THE LIGNTHEAD AND THE SPRING ARM. THIS SCREW ACTS AS A TRANSLATIONAL STOP AND A ROTATIONAL STOP. NO PHOTOGRAPHIC EVIDENCE OR DETAIL OF THE BROKEN SCREW WERE PROVIDED. THE SCREW WAS DAMAGED BECAUSE IT WAS PROBABLY SUBJECTED TO A LOT OF STRESS/IMPACT DURING HANDLING OVER A PERIOD OF MORE THAN 12 YEARS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Additional Manufacturer Narrative

INITIAL REPORTER: #PERSON IN CHAREGE. EVENT SITE NAME: (B)(6) HOSPITAL. 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. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 10/40. IT WAS STATED THE SAFETY SCREW WAS BROKEN RESULTING IN RISK OF HEADLIGHT'S DETACHMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY IN CASE OF REOCCURRENCE.