BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8 G8E

    MDR report key: 16494791 · Received March 7, 2023

    Report

    Report Number
    9710055-2023-00181
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 7, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF D4 CATALOG #, H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE -EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG #: ARD568121111C. CORRECTED D4 CATALOG #: ARD568102997. 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: BLANK. PREVIOUS H3C IF OTHER PROVIDE CODE -EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE -EXPLAIN: BLANK. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - G8 G8E. AS IT WAS STATED, UPON THE DEVICE INSPECTION SIX OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE BEING LOOSE AND, IN THIS WAY, CONTRIBUTED TO THE EVENT. INFORMATION GATHERED DURING THE INVESTIGATION INDICATES THAT THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT OCCURRED. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUES, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO FOR THE ISSUE INVESTIGATED HEREIN IS MODERATE. DURING THE ANALYSIS, SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE DETERMINED THE FOLLOWING TO HAVE LIKELY OCCURRED. A LOOSENING OF THE SCREW OR SCREWS, WHERE THE PROBABLE CAUSES OF LOOSENING CORRESPONDS TO AN IMPROPER INITIAL TIGHTENING DURING THE INSTALLATION OR A MAINTENANCE NOT IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS (INSTALLATION MANUAL G8E NI GBE 013842301 ED1, PAGES 12-13). 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. TO PREVENT ANY INCIDENT THE YEARLY PREVENTIVE MAINTENANCE PROGRAM, MENTIONS TO CHECK THE TIGHTENING OF FIXATION SCREWS ON THE SUSPENSION TUBE (TECHNICAL MANUAL 0138201 ED1L, PAGES 10-12). IN APRIL 2019 GETINGE TRANSMITTED THE SERVICE BULLETIN 98A ON GETINGE ONLINE REMINDING TO CARRY OUT PREVENTIVE MAINTENANCE AND WEARING PARTS REPLACEMENT TO ENSURE THE DEVICE SAFETY, THE SERVICE BULLETIN 98A MENTIONS TO REPLACE THE SUSPENSION FIXING SCREWS EVERY 6 YEARS DURING THE PREVENTIVE MAINTENANCE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER WAS GETINGE TECHNICIAN. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 20TH FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - G8 G8E. AS IT WAS STATED, UPON THE DEVICE INSPECTION SIX OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716384 G8 G8E LAMP, SURGICAL FTD MAQUET SAS ARD568121111C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown