PAIR OF LEG PLATES, 4-PART

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. EVENT SITE NAME (E1): KLINIK KITZINGER LAND H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 27TH JULY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 113373BC - PAIR OF LEG PLATES, 4-PART. AS IT WAS STATED, USER'S THUMB WAS PINCHED WHILE OPERATING THE RELEASE LEVER OF THE LEG PLATE LEADING TO A CUT. ACCORDING TO THE PROVIDED INFORMATION, THE CUT WAS DRESSED AND NO MEDICAL INTERVENTION WAS REQUIRED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR.

Description of Event or Problem

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 113373BC - PAIR OF LEG PLATES, 4-PART. AS IT WAS STATED, THE USER'S THUMB WAS PINCHED WHILE OPERATING THE RELEASE LEVER OF THE LEG PLATE LEADING TO A CUT. ACCORDING TO THE PROVIDED INFORMATION, THE CUT WAS DRESSED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE ISSUE LED TO A DELAY IN SURGERY OF APPROXIMATELY 15 MINUTES, BUT THERE IS NO INFORMATION THAT IT LED TO PROLONGED ANESTHESIA TIME FOR THE PATIENT. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING THE USE OF THE LEG PLATE, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS NO MALFUNCTION WITH THE DEVICE WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE ISSUE INVESTIGATED HEREIN IS 0,13% AS THERE WERE THREE SIMILAR REPORTABLE CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE. THE DEVICE WAS INSPECTED BY THE SALES REPRESENTATIVE. THERE WAS NO MALFUNCTION OF THE LEG PLATES. THE SITE WAS ALSO VISITED BY THE GETINGE SERVICE TECHNICIAN AND NO INTERVENTION WAS NECESSARY. THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE WAS CONTACTED TO ESTABLISH THE ROOT CAUSE OF THIS ISSUE. THE SME ASSESSED THAT THE DESIGN IMPLEMENTED IN THE AFFECTED LEG PLATES WAS DEVELOPED WITH SECURITY AGAINST UNWANTED RELEASE AND ANY PINCHING RISK COULD NOT BE IDENTIFIED. IN THE INSTRUCTION FOR USE (IFU 1333.73 EN 07, PAGE 11), THE USER IS INFORMED ABOUT DANGED RESULTING FROM IMPROPER HANDLING. THE USER IS ALSO WARNED (IFU 1333.73 EN 07, PAGE 11), THAT WHEN ADJUSTING, MOVING OR STORING OR TABLE/ TABLE TOP, THE STAFF, THE PATIENT AND THE ACCESSORIES ARE EXPOSED TO PINCHING AND SHEARING HAZARDS, PARTICULARLY IN THE AREA AROUND THE JOINTS AT THE HEAD REST, BACK AND LEG PLATES. THE USER SHALL ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS. IT IS LIKELY THAT THE USER UTILIZED THE LEG PLATES DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL. IN SUMMARY, THERE WAS NO MALFUNCTION OF THE INVESTIGATED LEG PLATES. BASED ON ALL AVAILABLE INFORMATION THE SME ESTABLISHED THAT THE ROOT CAUSE FOR THE USER'S THUMB BEING PINCHED, WHAT LED TO A CUT, WHILE OPERATING THE RELEASE LEVER OF THE LEG PLATE, WAS MOST LIKELY RELATED TO THE USER ERROR. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.