BACK PLATE FOR SHOULDER OPERATIONS W/SFC

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100718B0 - BACK PLATE FOR SHOULDER OPERATIONS W/SFC. THE ACCESSORY WAS USED WITH MOBILE TABLE - 113211A2 - ALPHASTAR MOBILE OPERATING TABLE AND TROLLEY 100720A0. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER, DUE TO MISALIGNMENT OF THE TABLE, IT WAS DIFFICULT TO FIT AND REMOVE ACCESSORY, WHICH CAUSED THE ACCESSORY TO FALL WHILE IT WAS BEING HANDLED BY NURSE. THE NURSE'S HAND WAS HIT DURING INCIDENT, BUT THE RADIOLOGICAL EXAMINATION DID NOT REVEAL ANY FRACTURE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FALL OF THE BACK PLATE ON STAFF MEMBER¿S HAND, WAS TO REOCCUR. THE AFFECTED GETINGE DEVICES HAVE BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN. THE TECHNICIAN CONFIRMED THE MISALIGNMENT OF THE OPERATING TABLE¿S SHORT BACKREST SPARS AND WAS ABLE TO ADJUST THEM WITHIN MANUFACTURER¿S TOLERANCE. THE TECHNICIAN ALSO NOTICED TROLLEY¿S BENT SUPPORT LEGS, WHICH MADE BACK PLATE ACCESSORY NO LONGER STABLE ON IT. THE TROLLEY CANNOT BE REPAIRED AND SHOULD NO LONGER BE USED. ON THE BACK PLATE ACCESSORY THERE WAS A SLIGHT OFFSET BETWEEN THE TWO PINS. THIS OFFSET COULD BE CORRECTED ON CUSTOMER¿S REQUEST, HOWEVER TWO USERS CAN HANDLE IT WITHOUT ANY DIFFICULTIES. IN THE INSTRUCTION FOR USE (GA 1007.20 EN 04, PAGE 6) THE USER IS WARNED THAT THE PRODUCT MAY ONLY BE USED WHEN FULLY FUNCTIONAL. IT WAS REPORTED THAT THE TROLLEY HAD BENT SUPPORT LEGS. THEREFORE, IT IS LIKELY THAT THE INSPECTION WAS NOT PERFORMED OR THAT IT WAS NOT PERFORMED SUFFICIENTLY. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT RECORD IT IS KNOWN THAT THE OPERATING TABLE WAS MISALIGNED CAUSING THE DIFFICULTIES WITH FITTING AND REMOVING THE ACCESSORY AND ON BACK PLATE THERE WAS ALSO A SLIGHT OFFSET. IT CAN BE CONCLUDED THAT THE REQUIREMENT FOR MOUNTING PROCEDURE DESCRIBED IN THE IFU (GA 1007.20 EN 04, PAGE 9) WAS NOT MET BY THE USER. AS IT IS VERY LIKELY THAT THE USER UTILIZED THE ACCESSORY DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL AND DID NOT PERFORM PROPER VISUAL AND FUNCTIONAL INSPECTION BEFORE USE, THE ROOT CAUSE FOR THE ISSUE, NAMELY THE BACK PLATE FALLING ON OR STAFF MEMBER¿S HAND IS USER ERROR. WITH THE INVESTIGATION PERFORMED, IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR THE PATIENT¿S TREATMENT. HOWEVER, IT WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTIONS OF THE BACK PLATE, OPERATING TABLE AND TROLLEY WERE FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICES WERE NOT UP TO THE SPECIFICATION. THE SITUATION IS CONSIDERED AS SINGLE AND ISOLATED PER A REVIEW PERFORMED AS PART OF THE INVESTIGATION. 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. THE CORRECTION OF B1 ADVERSE EVENT / PRODUCT PROBLEM AND B5 DESCRIBE EVENT OR PROBLEM FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B1 ADVERSE EVENT / PRODUCT PROBLEM: PRODUCT PROBLEM CORRECTED B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT & PRODUCT PROBLEM. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 18TH JANUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100718B0 - BACK PLATE FOR SHOULDER OPERATIONS W/SFC. THE ACCESSORY WAS USED WITH MOBILE TABLE - 113221B0 - ALPHASTAR PRO, EU, SFC. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER, DUE TO MISALIGNEMENT OF THE TABLE IT WAS DIFFICULT TO FIT AND REMOVE ACCESSORY WHICH CAUSED THE ACCESSORY TO FALL WHILE IT WAS BEING HANDLED BY NURSE. THE NURSE'S HAND WAS INJURED DURING INCIDENT. THE RADIOLOGICAL EXAMINATION WAS PERFOMED AND IT WAS CONCLUDED THAT THERE WAS NO FRACTURE. THE NURSE HAD A WEEK LONG SICK LEAVE. FURTHER INFORMATION REGARDING THE INJURY WAS REQUESTED FROM THE CUSTOMER, HOWEVER, NO UPDATE WAS RECEIVED BY THE TIME OF REPORTING. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FALL OF THE ACCESSORY RESULTING IN USER'S INJURY, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 18TH JANUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100718B0 - BACK PLATE FOR SHOULDER OPERATIONS W/SFC. THE ACCESSORY WAS USED WITH MOBILE TABLE - 113211A2 - ALPHASTAR MOBILE OPERATING TABLE AND TROLLEY 100720A0. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER, DUE TO MISALIGNMENT OF THE TABLE, IT WAS DIFFICULT TO FIT AND REMOVE ACCESSORY, WHICH CAUSED THE ACCESSORY TO FALL WHILE IT WAS BEING HANDLED BY A NURSE. THE NURSE'S HAND WAS HIT DURING INCIDENT. THE RADIOLOGICAL EXAMINATION WAS PERFORMED AND IT WAS CONCLUDED THAT THERE WAS NO FRACTURE. THE NURSE HAD A WEEK LONG SICK LEAVE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FALL OF THE BACK PLATE ON STAFF MEMBER¿S HAND, WAS TO REOCCUR.

Description of Event or Problem

ON 18TH JANUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100718B0 - BACK PLATE FOR SHOULDER OPERATIONS W/SFC. THE ACCESSORY WAS USED WITH MOBILE TABLE - 113211A2 - ALPHASTAR MOBILE OPERATING TABLE AND TROLLEY 100720A0. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER, DUE TO MISALIGNMENT OF THE TABLE, IT WAS DIFFICULT TO FIT AND REMOVE ACCESSORY, WHICH CAUSED THE ACCESSORY TO FALL WHILE IT WAS BEING HANDLED BY A NURSE. THE NURSE'S HAND WAS HIT DURING INCIDENT. THE RADIOLOGICAL EXAMINATION WAS PERFORMED AND IT WAS CONCLUDED THAT THERE WAS NO FRACTURE. THE NURSE HAD A WEEK LONG SICK LEAVE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FALL OF THE BACK PLATE ON STAFF MEMBER¿S HAND, WAS TO REOCCUR.

Description of Event or Problem

ON 18TH JANUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100718B0 - BACK PLATE FOR SHOULDER OPERATIONS W/SFC. THE ACCESSORY WAS USED WITH MOBILE TABLE - 113221B0 - ALPHASTAR PRO, EU, SFC. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER, DUE TO MISALIGNMENT OF THE TABLE IT WAS DIFFICULT TO FIT AND REMOVE ACCESSORY WHICH CAUSED THE ACCESSORY TO FALL WHILE IT WAS BEING HANDLED BY NURSE. THE NURSE'S HAND WAS INJURED DURING INCIDENT. THE RADIOLOGICAL EXAMINATION WAS PERFORMED AND IT WAS CONCLUDED THAT THERE WAS NO FRACTURE. THE NURSE HAD A WEEK LONG SICK LEAVE. FURTHER INFORMATION REGARDING THE INJURY WAS REQUESTED FROM THE CUSTOMER, HOWEVER, NO UPDATE WAS RECEIVED BY THE TIME OF REPORTING. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FALL OF THE ACCESSORY RESULTING IN USER'S INJURY, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.