BACK PLATE FOR SHOULDER OPERATIONS

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1B EVENT SITE NAME: (B)(6).

Description of Event or Problem

ON 11TH MARCH 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100721B0 - BACK PLATE F. SHOULDER OPERATIONS SFC, EU USED WITH 143302B0 - YUNO 2 EU WITH AUTODRIVE. AS IT WAS STATED, THE BACK PLATE UNFASTENED FROM THE TABLE MOUNTING LOCK WHAT OCCURRED DURING THE PROCEDURE. THE SITUATION ALLEGEDLY TOOK PLACE WHEN THE PATIENT WAS WAKING UP AND BEGAN TO FIDGET. THE ANESTHESIA NURSE MANAGED TO CATCH THE PATIENT AND PREVENT THE PATIENT'S FALL. FOLLOWING THE INCIDENT, THE PATIENT WAS TRANSFERRED TO ANOTHER BED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THE DEFECT COULD HAVE OCCURRED DUE TO EXCESSIVE LOAD ON THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE BACK PLATE WHICH COULD POTENTIALLY RESULT IN THE PATIENT FALL, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100721B0 - BACK PLATE F. SHOULDER OPERATIONS SFC,EU USED WITH 143302B0 - YUNO 2 EU WITH AUTODRIVE. AS IT WAS STATED, THE BACK PLATE UNFASTENED FROM THE TABLE MOUNTING LOCK WHICH OCCURRED DURING THE PROCEDURE. THE SITUATION ALLEGEDLY TOOK PLACE WHEN THE PATIENT WAS WAKING UP AND BEGAN TO FIDGET. THE ANESTHESIA NURSE MANAGED TO CATCH THE PATIENT AND PREVENT THE PATIENT'S FALL. FOLLOWING THE INCIDENT, THE PATIENT WAS TRANSFERRED TO ANOTHER BED. ACCORDING TO INFORMATION PROVIDED BY THE SERVICE TECHNICIAN, THE DEFECT COULD HAVE OCCURRED DUE TO EXCESSIVE LOAD ON THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE BACK PLATE WHICH COULD POTENTIALLY RESULT IN THE PATIENT FALL, 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 THE SNAP-IN CONNECTOR WAS FOUND TO BE DEFECTIVE, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. THE ISSUE INVESTIGATED HEREIN IS A SINGLE AND ISOLATED CASE. THE AFFECTED DEVICES WERE INSPECTED BY THE GETINGE SERVICE TECHNICIAN. AS IT WAS STATED BY THE TECHNICIAN THE SNAP-IN CONNECTOR (COMPONENT NUMBER 5060674) WAS FOUND TO BE DEFECTIVE. THE EQUIPMENT WAS SEVERELY DAMAGED BY THE MECHANICAL FORCE EXERTED, PROBABLY DURING A COLLISION, OVERLOADING, OR DURING ASSEMBLY. ACCORDING TO THE TECHNICIAN, THE AFFECTED DEVICE WAS REPAIRED AND IS FULLY OPERATIONAL. THE CUSTOMER WILL BE INSTRUCTED ABOUT THE CORRECT USE OF THE DEVICES BY THE INSTRUCTIONS FOR USE TO AVOID THE REOCCURRENCE IN THE FUTURE. IN THE INSTRUCTIONS FOR USE THE BACK PLATE FOR SHOULDER OPERATIONS (IFU 1007.21 REV. 13, PAGE 11), THE USER IS WARNED THAT FAULTY PRODUCTS MAY RESULT IN INJURIES. THE PROPER WORKING ORDER AND FULLY FUNCTIONAL STATE OF THE PRODUCT SHOULD BE CHECKED BEFORE USE. THE USER IS ALSO WARNED (IFU 1007.21 REV. 13, PAGE 12), THAT PRODUCTS/ACCESSORIES NOT ATTACHED PROPERLY MAY LOOSEN AND CAUSE INJURIES. THE CUSTOMER MUST ENSURE THAT PRODUCTS/ACCESSORIES ARE MOUNTED CORRECTLY AND THAT THE SECURING ELEMENTS (HANDLE SCREWS, CATCHES, LEVERS, ETC.) ARE CLOSED AND FIRMLY TIGHTENED, AND THAT MOVING PARTS ARE CORRECTLY SECURED. IN THE IFU (IFU 1007.21 REV. 13, PAGE 13), IT IS STATED THAT LOOSENED SECURING ELEMENTS MAY CAUSE INJURIES. WHEN MOUNTING, AND AFTER EVERY ADJUSTMENT, ALL OF THE LOCKING ELEMENTS OF THE PRODUCT (HANDLE SCREW, LOCKS, LEVERS, ETC.) SHOULD BE TIGHTENED. THE FIRM SEATING OF THE LOCKING ELEMENTS SHOULD BE CHECK. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE MOST POSSIBLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE BACK PLATE UNFASTENED FROM THE TABLE MOUNTING RESULTING IN POTENTIAL PATIENT FALL, WAS CAUSED BY USER ERROR AND NON-COMPLIANCE WITH THE USER MANUAL. 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 D1 BRAND NAME, D4 CATALOG #, D11 CONCOMITANT PRODUCTS, H6 MEDICAL DEVICE ¿ PROBLEM CODE AND H6 COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: BACK PLATE F. SHOULDER OPERATIONS SFC,EU CORRECTED D1 BRAND NAME: BACK PLATE FOR SHOULDER OPERATIONS PREVIOUS D4 CATALOG #: 100721B0, CORRECTED D4 CATALOG #: N/A. PREVIOUS D11 CONCOMITANT PRODUCTS: 143302B0 - YUNO 2 EU WITH AUTODRIVE. CORRECTED D11 CONCOMITANT PRODUCTS: 143302B0 - YUNO II MOBILE OPERATING TABLE. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/STRUCTURAL PROBLEM/DIFFICULT TO OPEN OR CLOSE/2921. MECHANICAL PROBLEM/UNINTENDED MOVEMENT//3026. PREVIOUS H6 COMPONENT CODES: MECHANICAL/CONNECTOR/COUPLER//4733. CORRECTED H6 COMPONENT CODES: SAFETY/LOCKING MECHANISM//3083.

Description of Event or Problem

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