CHROMOPHARE OR LIGHT CEILING-MOUNTED

Additional Manufacturer Narrative

IT WAS REPORTED IN OR 15 PRIOR TO PROCEDURE A LIGHT HEAD BECAME DISENGAGED FROM A SPRING ARM AND STRUCK A DOCTOR, WHO NEEDED MEDICAL INTERVENTION FOR ALLEGED CRACKED RIBS. THERE WAS NO REPORTED PATIENT INVOLVEMENT IN THIS EVENT. THE ROOT CAUSE OF THE ISSUE IN OR15 WAS DETERMINED TO BE SEPARATION OF MOUNTING HARDWARE DUE TO A CRACKED COVER CASING THE HARDWARE. THE COVER HELPS RETAIN MOUNTING HARDWARE THAT ENSURES THE LIGHT IS CONSTRAINED TO THE SPRING ARM. AFTER A FIELD INVESTIGATION, IT APPEARS THE COVER WAS DAMAGED, WHICH RESULTED IN A CHANGED SPACING AROUND THE MOUNTING HARDWARE. THIS ALLOWED THE HARDWARE TO GET OUT OF POSITION. IT IS UNCLEAR HOW LONG THE LIGHT EXISTED IN THIS STATE BEFORE FAILURE, AS NO SERVICE EVENTS WERE REPORTED TO STRYKER CONCERNING THESE CRACKED COMPONENTS. AFTER INITIAL INSPECTION AND BASED ON CURRENT INFORMATION, THE SUSPECTED ROOT CAUSE OF THE CRACKING IS CLEANING METHOD. IF ANY FURTHER INFORMATION IS FOUND; A SUPPLEMENTAL WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED IN OR 15 PRIOR TO PROCEDURE A LIGHT HEAD FELL OFF OF A SPRING ARM AND STRUCK A DOCTOR, WHO NEEDED MEDICAL INTERVENTION FOR CRACKED RIBS. THERE WAS NO REPORTED PATIENT INVOLVEMENT IN THIS EVENT.

Additional Manufacturer Narrative

THERE HAS BEEN CORRECTED DATA UPDATES MADE TO THE FOLLOWING FIELDS: OUTCOMES ATTRIBUTED TO AE, CLINICAL SIGNS CODE GRID, HEALTH IMPACT CODE GRID, AND COMPONENT CODE GRID.

Description of Event or Problem

IT WAS REPORTED IN OR 15 PRIOR TO PROCEDURE A LIGHT HEAD FELL OFF OF A SPRING ARM AND STRUCK A DOCTOR, WHO NEEDED MEDICAL INTERVENTION FOR CRACKED RIBS. THERE WAS NO REPORTED PATIENT INVOLVEMENT IN THIS EVENT.