BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROSKOP OMNIA MAX

    MDR report key: 16626586 · Received March 28, 2023

    Report

    Report Number
    3004977335-2023-00015
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 14, 2023
    Report Date
    June 21, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K173639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11 CORRECTED DATA/CLARIFICATION: B1, B2, H1: THE EVENT WAS RE-CLASSIFIED AS AN ADVERSE EVENT UPON COMPLETION OF THE INVESTIGATION AND THIS INFORMATION WAS OMITTED IN ERROR IN FOLLOW-UP REPORT 1, SUBMITTED TO THE FDA ON (B)(6) 2023. H3, H6: ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS UNDERGOING AN EXAMINATION (BLADDER AND KIDNEY) ON (B)(6) 2023, WHEN THE COMPLAINT EVENT OCCURRED (FOOTREST DETACHED AND THE PATIENT FELL). THE PATIENT REPORTED PAIN IN THE COCCYX, BACK AND RIGHT KNEE REGIONS AFTER THE FALL. ALTHOUGH THERE WAS NO PHYSICAL EVIDENCE OF INJURY, THE PATIENT UNDERWENT X-RAY EXAMINATION OF THESE REGIONS. THE PATIENT WAS DIAGNOSED WITH AN ACUTE LOW-DISPLACEMENT FRACTURE OF THE OS SACRUM AND WAS TOLD TO SEE AND ORTHOPEDIST THE FOLLOWING DAY, (B)(6) 2023. ADDITIONAL INFORMATION REGARDING THE PATIENT'S HEALTH STATUS AND TREATMENT WERE NOT PROVIDED TO SIEMENS HEALTHCARE. G2: ADDITIONAL REPORT SOURCE WAS ADDED.

    Additional Manufacturer Narrative · 0

    H10 MANUFACTURER NARRATIVE: H3, H6: SIEMENS HEALTHCARE INVESTIGATED THE REPORTED ISSUE IN DETAIL. IT WAS STATED THAT THE MECHANICAL LOCK OF THE FOOTBOARD BROKE DURING PATIENT OPERATION. ACCORDING TO FURTHER INFORMATION PROVIDED, THE PATIENT CLAIMED OF PAIN IN THE COCCYX, BACK AND RIGHT KNEE. THE PATIENT RECEIVED IMMEDIATE MEDICAL CARE. THE FOOTBOARD WAS REPLACED ON SITE. IT WAS CONFIRMED THAT THE NEW FOOTBOARD COULD BE SAFELY INSTALLED AND USED. THE AFFECTED PART WAS PROVIDED FOR FURTHER INVESTIGATION. IT WAS DESCRIBED THAT THE FOOTBOARD HAD BROKEN FROM THE TABLETOP. HOWEVER, THIS COULD NOT BE CONFIRMED DURING THE INVESTIGATION. THE ISSUE COULD NOT BE REPRODUCED ON SITE. ONLY NORMAL WEAR AND NO DEFECT OR DAMAGE IS VISIBLE ON THE AFFECTED FOOTBOARD. THE FOOTBOARD COULD BE ATTACHED SAFELY TO THE UROSKOP OMNIA MAX SYSTEM IN THE LABORATORY. IT IS THEREFORE ASSUMED THAT THE FOOTREST HAD FALLEN OFF. THE SPARE PART CONSUMPTION OF THE AFFECTED PART (MATERIAL NUMBER 7453827) WAS CHECKED. NO GENERAL PROBLEM WAS FOUND. BASED ON THE INFORMATION AVAILABLE AND THE EXPERIENCE OF THE PRODUCT EXPERTS, IT IS ASSUMED THAT THE FOOTBOARD HAS DETACHED DUE TO IMPROPER USE OR INCORRECT ATTACHMENT. IF THE FOOTBOARD IS NOT PROPERLY ATTACHED, IT MAY COME LOOSE DURING PATIENT OPERATION. IN GENERAL, IT IS RECOMMENDED TO CHECK THE FOOTREST AGAIN BEFORE EACH USE TO ENSURE THAT IT IS PROPERLY SECURED. THE CORRECT ATTACHMENT AND USE OF THE FOOTREST IS DESCRIBED IN THE OPERATOR MANUAL (XPL5-360.621.02.01.02 ON PAGE 58/59 - FOOTBOARD). THE COMPLAINT IS CLOSED WITH THIS STATEMENT AND WITHOUT FURTHER MEASURES.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER FACILITY PHONE NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITION INFORMATION BECOMES AVAILABLE UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    DURING A PATIENT EXAMINATION, WITH THE SYSTEM IN A 90-DEGREE (VERTICAL) POSITION, THE FOOT BOARD DETACHED FROM THE SYSTEM WHILE THE PATIENT WAS STANDING ON IT. ADDITIONAL INFORMATION REGARDING PATIENT INJURY HAS NOT BEEN RECEIVED. IN A WORST-CASE SCENARIO IF THIS ISSUE WERE TO RECUR, A PATIENT COULD SUSTAIN INJURY FROM A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555116 UROSKOP OMNIA MAX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10762473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other