BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 17594094 · Received August 22, 2023

    Report

    Report Number
    9710055-2023-00597
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 15, 2023
    Report Date
    August 22, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - XTEN. IT WAS STATED THE SCREW OF THE SHADOWLESS LAMP IS BROKEN CAUSING THE SHADOWLESS LAMP TO FALL OFF. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, THE SUSPENSION ARM AND SCREW WERE RUSTED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BROKEN AND RUSTED SCREW COULD LEAD TO FALL OF THE DEVICE DURING OPERATION PROCEDURE AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED BEFORE OPERATION. A TECHNICAL EVALUATION OF RUST WAS PERFORMED BY SUBJECT MATTER EXPERTS WHO STATED THAT: THE PHOTOGRAPHIC EVIDENCE SHOW RUST FORMATION AND PAINT PEELING ON THE DEVICE. IT CAN BE OBSERVED THAT THE DEGRADATION OF THE PAINT AND CORROSION ARE MOSTLY LOCALIZED ON THE RETENTION AREAS WHICH SHOWS THAT THE STAGNATION OF LIQUID OR CLEANING AGENT RESIDUES HAVE CAUSED PAINT DAMAGES AND APPEARANCE OF RUST. PEELING PAINT AND RUST FORMATION WERE PROBABLY CAUSED BY: A STAGNATION OF AGGRESSIVE DISINFECTANT AND DETERGENT PRODUCTS DUE TO AN INAPPROPRIATE CLEANING PROTOCOL. THE PRESENCE OF LIQUID WATER OR AN EXPOSURE TO HUMID AIR DUE TO A HIGH RELATIVE HUMIDITY OF THE OPERATING ROOM. THE INSTRUCTION FOR USE INDICATES THE ENVIRONMENTAL CONDITION FOR USE, THE RELATIVE HUMIDITY MUST BE BETWEEN 20% AND 75%. TO PREVENT ANY INCIDENT THE INSTRUCTION FOR USE MENTIONS TO PERFORM DAILY AND MONTHLY INSPECTION IN ORDER TO DETECT PAINTING DEFECTS, IMPACT MARKS OR OTHER DAMAGES. THE INSTRUCTION FOR USE MENTIONS NOT TO CLEAN THE DEVICE UNDER RUNNING WATER NOR SPRAY A SOLUTION DIRECTLY ONTO THE DEVICE. CERTAIN CLEANING PRODUCTS OR PROCEDURES MAY DAMAGE THE PAINTWORK OF THE DEVICE, WHICH MAY RESULT IN PARTICLES FALLING ONTO THE SURGICAL SITE DURING AN OPERATION. FUMIGATION METHODS ARE UNSUITABLE FOR DISINFECTING THE UNIT AND MUST NOT BE USED. THE INSTRUCTION FOR USE MENTIONS TO WIPE WITH A DRY CLOTH AND TO MAKE SURE NO LIQUID RESIDUE IS LEFT ON THE DEVICE AFTER CLEANING. REGARDING TO THE ISSUE WITH SCREWS: IN CASE OF LOOSENING, THE PROBABLE CAUSES OF LOOSENING CORRESPOND TO AN IMPROPER INITIAL TIGHTENING DURING THE INSTALLATION OR A MAINTENANCE NOT IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. IN CASE OF RUPTURE, THE FAILURE OF THE SCREWS IS RELATED TO FATIGUE STRESSES DUE TO MODERATE SHEAR OVERLOAD. ALL FACIES HAVE A FATIGUE FAILURE ZONE MORE OR LESS EXTENSIVE. INITIATED AT THE BOTTOM OF THE THREAD, THE REPEATED LOW MECHANICAL STRESSES CAUSED THE BREAKAGE OF A FIRST SCREW. THE RUPTURE OF THE OTHER SCREWS CORRESPONDS TO PROGRESSIVE PROPAGATION OF THE SHEAR EFFECT. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM MENTIONS: TO CHECK THE SUSPENSION FIXING SCREWS. IT IS ALSO INDICATED TO NOT RETIGHTEN THE SCREWS DURING MAINTENANCE. IF SCREWS APPEAR LOOSENED REPLACE THEM. TO REPLACE THE 6 FIXING SCREWS EVERY 6 YEARS. IN APRIL 2019 GETINGE TRANSMITTED THE SERVICE BULLETIN 98 ON GETINGE ONLINE REMINDING TO CARRY OUT PREVENTIVE MAINTENANCE AND WEARING PARTS REPLACEMENT TO ENSURE THE DEVICE SAFETY. THE SERVICE BULLETIN 98 MENTIONS TO REPLACE THE SUSPENSION FIXING SCREWS EVERY 6 YEARS DURING THE PREVENTIVE MAINTENANCE. MOREOVER, THE VOLUNTARY FSCA-808092, RELATING THE MAINTENANCE PROGRAM ON MAQUET SAS¿ OR LIGHT SYSTEMS, WAS COMMUNICATED IN SEPTEMBER 2023, IN ORDER TO FOCUS ESPECIALLY THE PERIODIC REPLACEMENT OF THE SUSPENSION FIXING SCREWS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE INITIAL REPORTER WAS CLEANING STAFF. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016. THE CORRECTION OF D4 VERSION OR MODEL #, D4 CATALOG #, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 VERSION OR MODEL #: ARD568223912C; CORRECTED D4 VERSION OR MODEL #: ARD567827999. PREVIOUS D4 CATALOG # ARD568223912C; CORRECTED D4 CATALOG # ARD567827999. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO; CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER; CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER; CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. PREVIOUS H6 COMPONENT CODES: MECHANICAL/FASTENER/SCREW/568; OPTICAL/LIGHT SOURCE//4749. CORRECTED H6 COMPONENT CODES: MECHANICAL/FASTENER/SCREW/568.

    Description of Event or Problem · 0

    ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - XTEN. IT WAS STATED THE SCREW OF THE SHADOWLESS LAMP IS BROKEN CAUSING THE SHADOWLESS LAMP TO FALL OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BROKEN SCREW COULD LEAD TO FALL OF THE DEVICE DURING OPERATION PROCEDURE AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.

    Description of Event or Problem · 0

    ON 16TH AUGUST 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - XTEN. IT WAS STATED THE SCREW OF THE SHADOWLESS LAMP IS BROKEN CAUSING THE SHADOWLESS LAMP TO FALL OFF. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, THE SUSPENSION ARM AND SCREW WERE RUSTED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BROKEN AND RUSTED SCREW COULD LEAD TO FALL OF THE DEVICE DURING OPERATION PROCEDURE AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341046 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567827999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown