GSS67

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ON JANUARY 15, 2024 GETINGE BECAME AWARE OF AN EVENT WHICH TOOK PLACE ON JANUARY 12, 2024 ON GSS67H STERILIZER. AS IT WAS STATED THE OPERATOR WAS INJURED WHILE CLOSING THE DEVICE¿S DOOR. IN MORE DETAILS, THE DOOR ON THE UNLOADING SIDE CLOSED HALFWAY. THE EMPLOYEE WANTED TO CLOSE IT WITH HIS HAND. THE DOOR CAME UP SUDDENLY. THE OPERATOR MANAGED TO REMOVE HIS HAND PARTIALLY, BUT HIS TWO FINGERS (RIGHT RING FINGER AND MIDDLE FINGER) GOT PINCHED - THE SKIN HAS BEEN REMOVED, LEAVING THE FLESH UNDERNEATH EXPOSED. VISIT AT THE EMERGENCY DEPARTMENT WAS NEEDED. THE EMPLOYEE WAS RECOMMENDED 15 DAYS OF SICK LEAVE. THE INJURY IS CLASSIFIED AS SERIOUS AS IT WAS A CONDITION NECESSITATING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE. REF- (B)(6).

Additional Manufacturer Narrative

ON JANUARY 15, 2024, GETINGE BECAME AWARE OF ISSUE WITH GSS67H STERILIZER WITH THE SERIAL NUMBER (B)(6). THE DEVICE WAS MANUFACTURED ON AUGUST 11, 2023. AS IT WAS STATED THE OPERATOR WAS INJURED WHILE CLOSING THE DEVICE¿S DOOR. THE DOOR ON THE UNLOADING SIDE CLOSED HALFWAY. THE EMPLOYEE WANTED TO CLOSE IT WITH HIS HAND. THE DOOR CAME UP SUDDENLY. THE OPERATOR MANAGED TO REMOVE HIS HAND PARTIALLY, BUT HIS TWO FINGERS (RIGHT RING FINGER AND MIDDLE FINGER) GOT PINCHED. THE INJURY IS CLASSIFIED AS SERIOUS AS IT WAS A CONDITION NECESSITATING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE. VISIT AT THE EMERGENCY DEPARTMENT WAS NEEDED. THE EMPLOYEE WAS RECOMMENDED 15 DAYS OF SICK LEAVE. THE AFFECTED GETINGE DEVICE HAS BEEN EVALUATED BY THE GETINGE SERVICE TECHNICIAN. THE TECHNICIAN DID NOT CONFIRM A MALFUNCTION OF THE STERILIZER. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES FOR GSS67H WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE SECOND ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS OF ITS KIND. IT WAS CONFIRMED THAT WHEN THE EVENT OCCURRED, THE DEVICE WAS DIRECTLY INVOLVED AND DID NOT MEET ITS SPECIFICATION DUE TO DOOR OBSTRUCTION. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON THE PERFORMED ROOT CAUSE ANALYSIS AND INPUT FROM THE SUBJECT MATTER EXPERT AND THE GETINGE TECHNICIAN WHO VISITED THE CUSTOMER WE CONCLUDE THAT ROOT CAUSE OF THE FINGER¿S INJURY IS RELATED TO USER ERROR. THE DOOR SHOULD NOT BE PULLED UP TO HELP WITH CLOSING. IF THE DOOR MOVEMENT WAS OBSTRUCTED IN ANY WAY DURING THE CLOSING PROCEDURE AND THEN BY ALSO LIFTING THE CRUSH PROTECTION UPWARDS, IT COULD BE THE CAUSE OF THE RAPID MOVEMENT UPWARDS. HOWEVER, THE EXACT ROOT CAUSE WHY THE DOOR DID NOT MOVE FROM THE BEGINNING AND GOT STUCK HALFWAY UP WAS NOT CONFIRMED ¿ THERE WAS NO SIGN OF ANY DEVIATION OF SPECIFICATION AFTER DEVICE INSPECTION. THERE IS A POSSIBILITY THAT SOMETHING FROM THE LOAD GOT STUCK BETWEEN THE DOOR PLATE AND THE CHAMBER GASKET GROOVE BUT IT IS IMPOSSIBLE TO CONFIRM THIS SCENARIO. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.

Description of Event or Problem

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