LEG HOLDER, PAIR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES, 100586B0 - LEG HOLDER (PAIR). DURING A PROCEDURE, THE ACCESSORY BROKE WHILE A PATIENT WAS BEING POSITIONED. THE DEVICE WAS REPLACED WITH A NEW ONE. BASED ON THE INFORMATION RECEIVED, THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT. ADDITIONAL DETAILS ABOUT THE INCIDENT WERE REQUESTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. WE DECIDED TO REPORT THE ISSUE DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ACCESSORY BREAKING DURING PATIENT INSTALLATION, WHICH COULD CAUSE UNINTENDED MOVEMENT OF THE LEG HOLDER, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES, 100586B0 - LEG HOLDER (PAIR). DURING A PROCEDURE, THE ACCESSORY BROKE WHILE A PATIENT WAS BEING POSITIONED. THE DEVICE WAS REPLACED WITH A NEW ONE. BASED ON THE INFORMATION RECEIVED, THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT. WE DECIDED TO REPORT THE ISSUE DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ACCESSORY BREAKING DURING PATIENT INSTALLATION, WHICH COULD HAVE RESULTED IN AN UNINTENDED MOVEMENT, WAS TO REOCCUR. THE DEVICE WAS INITIALLY PLACED IN QUARANTINE BY THE USER FOR SAFETY REASONS. SUBSEQUENTLY, IT WAS SCRAPPED, AND A REPLACEMENT UNIT WAS PROVIDED TO THE CUSTOMER. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE ACCESSORY MALFUNCTIONED DURING THE SURGERY, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS FOUND NO PAST REPORTS OF SIMILAR INCIDENTS RESULTING IN INJURY TO EITHER A PATIENT OR AN OPERATOR. THE DEVICE SUSTAINED STRUCTURAL DAMAGE AS A PART FELL OFF OR A COMPONENT DETACHED FROM THE ACCESSORY. HOWEVER, THE SPECIFIC DAMAGED COMPONENT COULD NOT BE IDENTIFIED. THE DEVICE WAS MANUFACTURED IN 2019. THEREFORE, THE DAMAGE CANNOT BE ATTRIBUTED TO NORMAL WEAR AND TEAR DUE TO THE AGE OF THE DEVICE, AS IT IS DESIGNED TO HAVE A 10-YEAR LIFESPAN. DESPITE SEVERAL REQUESTS, IT WAS NOT POSSIBLE TO OBTAIN A DESCRIPTION OF THE EXACT FAILURE MODE OR ANY EVIDENCE INDICATING POTENTIAL MISUSE BY THE CUSTOMER. THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE WAS CONSULTED TO ASSESS THE MOST PROBABLE ROOT CAUSE. IT WAS CONFIRMED THAT IN ORDER TO PERFORM A CONCLUSIVE ROOT CAUSE ANALYSIS, THE DEFECTIVE LEG HOLDER ITSELF WOULD BE REQUIRED. DESPITE REPEATED ATTEMPTS TO ARRANGE SHIPMENT OF THE DEVICE FOR EVALUATION, IT WAS ULTIMATELY SCRAPPED. AS A RESULT, A DETAILED ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE REMAINS IMPOSSIBLE TO DEFINE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING 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 B5 DESCRIBE EVENT OR PROBLEM, D9 DEVICE AVAILABLE FOR EVAL?, H3B DEVICE NOT EVAL PROVIDE CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES, 100586B0 - LEG HOLDER (PAIR). DURING A PROCEDURE, THE ACCESSORY BROKE WHILE A PATIENT WAS BEING POSITIONED. THE DEVICE WAS REPLACED WITH A NEW ONE. BASED ON THE INFORMATION RECEIVED, THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT. ADDITIONAL DETAILS ABOUT THE INCIDENT WERE REQUESTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. WE DECIDED TO REPORT THE ISSUE DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ACCESSORY BREAKING DURING PATIENT INSTALLATION, WHICH COULD CAUSE UNINTENDED MOVEMENT OF THE LEG HOLDER, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES, 100586B0 - LEG HOLDER (PAIR). DURING A PROCEDURE, THE ACCESSORY BROKE WHILE A PATIENT WAS BEING POSITIONED. THE DEVICE WAS REPLACED WITH A NEW ONE. BASED ON THE INFORMATION RECEIVED, THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT. WE DECIDED TO REPORT THE ISSUE DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ACCESSORY BREAKING DURING PATIENT INSTALLATION, WHICH COULD HAVE RESULTED IN AN UNINTENDED MOVEMENT, WAS TO REOCCUR. PREVIOUS D9 DEVICE AVAILABLE FOR EVAL?: YES. CORRECTED D9 DEVICE AVAILABLE FOR EVAL?: NO. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: OTHER.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES, 100586B0 - LEG HOLDER (PAIR). DURING A PROCEDURE, THE ACCESSORY BROKE WHILE A PATIENT WAS BEING POSITIONED. THE DEVICE WAS REPLACED WITH A NEW ONE. BASED ON THE INFORMATION RECEIVED, THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT. WE DECIDED TO REPORT THE ISSUE DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ACCESSORY BREAKING DURING PATIENT INSTALLATION, WHICH COULD HAVE RESULTED IN AN UNINTENDED MOVEMENT, WAS TO REOCCUR.