BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA STANDOP

    MDR report key: 18835666 · Received March 5, 2024

    Report

    Report Number
    9710055-2024-00190
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 5, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, H6 MEDICAL DEVICE ¿ PROBLEM CODE, H6 INVESTIGATION FINDINGS AND H6 INVESTIGATION CONCLUSIONS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 28TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - VOLISTA STANDOP. IT WAS STATED THAT THE CAP HAS FELL OUT OF THE CENTAL TUBE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 28TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - VOLISTA STANDOP. IT WAS STATED THAT THE CAP HAS FELL OUT OF THE CENTRAL TUBE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE INDICATED THAT CABLES FROM THE LCD MONITOR PASS THROUGH THE CAP, SO IT CANNOT FALL OUT. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO RISK OF CAP FALLING, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: NO APPARENT ADVERSE EVENT///3189. PREVIOUS H6 INVESTIGATION FINDINGS: RESULTS PENDING COMPLETION OF INVESTIGATION///3233 CORRECTED H6 INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND///213. PREVIOUS H6 INVESTIGATION CONCLUSIONS: CONCLUSION NOT YET AVAILABLE//11 CORRECTED H6 INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED//67. INITIALLY PROVIDED INFORMATION WAS POINTING TO CAP FALLING OFF FROM DEVICE. THE ISSUE IS CONSIDERED AS SAFETY RELATED AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. ACCORDING TO ADDITIONAL CLARIFICATION PROVIDED BY THE GETINGE TECHNICIAN, THE INITIAL INFORMATION WAS INCORRECT. IT WAS DETERMINED THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED AS THERE WAS NO INDICATION OF CAP FALLING OFF- CABLES FROM THE LCD MONITOR PASS THROUGH THE CAP, SO IT CANNOT FALL OUT EVEN IF IT IS LOOSENED. THE INVESTIGATION WAS PERFORMED. THE INVESTIGATED SCENARIOS DID NOT CAUSE RISK TO HUMAN LIFE. THE REVIEW OF THE CUSTOMER PRODUCT COMPLAINTS, RELATED TO INVESTIGATED ISSUE IN TIME, SHOWS THAT THERE IS NO REGULAR INCOME. NO APPARENT REASON WAS IDENTIFIED FOR SUGGESTING TO OPEN A CAPA OR EVALUATION FOR THE NEED OF ANOTHER ACTION IN THE MARKET.

    Description of Event or Problem · 0

    ON 28TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - VOLISTA STANDOP. IT WAS STATED THAT THE CAP HAS FELL OUT OF THE CENTAL TUBE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Description of Event or Problem · 0

    ON 28TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - VOLISTA STANDOP. IT WAS STATED THAT THE CAP HAS FELL OUT OF THE CENTRAL TUBE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE INDICATED THAT CABLES FROM THE LCD MONITOR PASS THROUGH THE COVER, SO IT CANNOT FALL OUT. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO RISK OF COVER FALLING, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477473 VOLISTA STANDOP LAMP, SURGICAL FTD MAQUET SAS ARD2VST00960A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown