RADIAL SETTING CLAMP

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 100323C0 - RADIAL SETTING CLAMP USED WITH 100257A0 ANESTHESIA SCREEN AND 113112B0 - BETASTAR MOBILE OPERATING-TABLE, EU. AS IT WAS STATED, AT THE END OF THE SURGERY (HYSTERECTOMY), THE ANESTHESIA SCREEN SUDDENLY SLIPPED. THE SURGEON WAS ABLE TO CATCH THE ACCESSORY IN TIME AND PREVENT THE PATIENT FROM BEING HIT. ACCORDING TO THE PROVIDED INFORMATION, THE AFFECTED ACCESSORY WAS FOUND LOOSE AND SLIPPING BEFORE THE SURGERY STARTED AND ALL THE JOINTS WERE TIGHTENED. FOLLOWING THE INCIDENT, THE ANESTHESIA SCREEN WAS CHECKED BY THE NURSE AND IT HAS BEEN ESTABLISHED THAT THE SCREWS THAT HAD BEEN FIXED BEFORE SURGERY WERE FOUND TO BE LOOSE AGAIN. THE EVENT DID NOT LEAD TO A DELAY IN TREATMENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR. THE CUSTOMER FAILED TO PROVIDE A PHOTO OR LABEL OF THE ANESTHESIA SCREEN USED AT THAT TIME, AND THERE MAY BE SITUATIONS WHERE THE SAME TYPE OF DEVICE WAS USED INTERCHANGEABLY IN DIFFERENT OPERATING ROOMS. ACCORDING TO THE CUSTOMER THE DROP OF THE ACCESSORY OCCURRED BEFORE AND AFTER THE SAME SURGERY. BEFORE THE SURGERY THE CUSTOMER FOUND OUT THAT THE ANESTHESIA SCREEN WAS LOOSE AND FELL OFF AND AFTER TIGHTENING THE SCREWS FOR THE SURGERY, IT LOOSENED AGAIN. THE CUSTOMER INDICATED THAT THE FASTENING SCREW OF THE ACCESSORY WAS WORN, WHICH MADE IT IMPOSSIBLE TO FASTEN THE ANESTHESIA SCREEN. ACCORDING TO THE TECHNICIAN, WEAR IS OFTEN CAUSED BY PULLING OUT OR ADJUSTING THE HEIGHT OF THE ANESTHESIA SCREEN WITHOUT FULLY LOOSENING THE FASTENING SCREW OF THE ANESTHESIA SCREEN FOR A LONG TIME, WHICH CAUSES THE FASTENING SCREW TO WEAR UNDER FORCE. THESE CLAIMS AND OBSERVATIONS COULD NOT BE CONFIRMED ON SITE. THE CUSTOMER DID NOT SUBMIT A REPAIR REPORT, AND THERE WERE NO KNOWN PARTS OR ACCESSORIES THAT WERE DAMAGED OR REPAIRED. AFTER GETINGE PERSONNEL WENT TO THE SCENE, THE CUSTOMER FAILED TO SHOW THE INVOLVED ACCESSORIES. THE GETINGE SERVICE TECHNICIAN WAS REQUESTED TO VISIT THE CUSTOMER AGAIN TO INSPECT THE AFFECTED DEVICES. HOWEVER, IT WAS STATED THAT THE VISIT WAS NOT POSSIBLE. IN THE INSTRUCTIONS FOR USE (IFU 1003.23 EN 08, PAGE 23) THE CUSTOMER CAN FIND INFORMATION THAT WEAR CAUSED BY USE AND AGE MAY INFLUENCE THE SAFETY-RELEVANT FUNCTIONS OF THE PRODUCT. THE CUSTOMER SHALL CHECK THE STATE OF THE PRODUCT PRIOR TO EACH USE. IF DEFECTS ARE DISCOVERED, THE USER SHALL NOT CONTINUE TO USE THE PRODUCT AND THE USER SHALL INFORM THE RELEVANT GETINGE REPRESENTATIVE FOR REPAIRS. IN THE IFU (IFU 1003.23 EN 08, PAGE 12), THE USER IS WARNED THAT PRODUCTS/ ACCESSORIES NOT ATTACHED PROPERLY MAY LOOSEN AND CAUSE INJURIES. THE USER SHALL ENSURE THAT PRODUCTS / ACCESSORIES ARE MOUNTED CORRECTLY AND THAT THE SECURING ELEMENTS (HANDLE SCREWS, CATCHES, LEVERS, ETC.) ARE CLOSED AND FIRMLY TIGHTENED. THE USER SHALL ALSO ENSURE THAT MOVING PARTS ARE CORRECTLY SECURED. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICES WERE BEING USED FOR THE PATIENT¿S TREATMENT, THUS WERE ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. THE DEVICES WERE NOT INSPECTED BY THE GETINGE SERVICE TECHNICIAN AND IT WAS NOT POSSIBLE TO ESTABLISH IF THE DEVICE WAS WORKING UP TO ITS SPECIFICATION OR NOT. THE RADIAL SETTING CLAMP WAS MANUFACTURED IN 2017 AND THE PRODUCTION DATE OF ANESTHESIA SCREEN IS UNKNOWN. HOWEVER, AS THE SUSPECTED ERROR PATTERN IMPLYING PARTS WEAR AND TEAR COULD HAVE NOT BEEN CONFIRMED ON SITE, THE ROOT CAUSE FOR THIS ISSUE REMAINS IMPOSSIBLE TO DEFINE. THERE WAS ONE SIMILAR CUSTOMER PRODUCT COMPLAINT RELATED TO THIS ISSUE INVESTIGATED HERE WHERE ANESTHESIA SCREEN SUDDENLY SLIPPED. THE FAILURE RATIOS FOR THE ISSUE INVESTIGATED HEREIN ARE LOW BOTH FOR THE 100323C0 RADIAL SETTLING CLAMP AND THE CONFIGURATION OF THE 100323C0 RADIAL SETTLING CLAMP, ALL VERSIONS OF 100257 ANESTHESIA SCREENS AND THE BETASTAR MOBILE OPERATING TABLES. 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 DEVICE WAS MANUFACTURED IN 2017.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1 EVENT SITE NAME: HUAXI NO.2 HOSPITAL OF SICHUAN UNIVERSITY H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 1ST JUNE 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 100323C0 - RADIAL SETTING CLAMP USED WITH 100257A0 ANESTHESIA SCREEN AND 113112B0 - BETASTAR MOBILE OPERATING-TABLE, EU. AS IT WAS STATED, AT THE END OF THE SURGERY (HYSTERECTOMY), THE ANESTHESIA SCREEN SUDDENLY SLIPPED. THE SURGEON WAS ABLE TO CATCH THE ACCESSORY IN TIME AND PREVENT THE PATIENT FROM BEING HIT. ACCORDING TO THE PROVIDED INFORMATION, THE AFFECTED ACCESSORY WAS FOUND LOOSE AND SLIPPING BEFORE THE SURGERY STARTED AND ALL THE JOINTS WERE TIGHTENED. FOLLOWING THE INCIDENT THE ANESTHESIA SCREEN WAS CHECKED BY THE NURSE AND IT HAS BEEN ESTABLISHED THAT THE SCREWS THAT HAD BEEN FIXED BEFORE SURGERY WERE FOUND TO BE LOOSE AGAIN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.