BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA MICROSCOPE DRAPE

    MDR report key: 10239820 · Received July 7, 2020

    Report

    Report Number
    3003623887-2020-00001
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    May 31, 2020
    Report Date
    July 7, 2020
    Manufacturer
    PHAMASEPT LTD. MEDICAL PRODUCTS
    Product Code
    HRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DESCRIBE THE EVENT OR PROBLEM: MICROSCOPE DRAPES X2 EACH HAD A RIP AT THE SEAM AT THE OCULAR PIECE. NO PATIENT EXPOSURE OR INJURY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : SPINE CERVICAL BELOW C2, ARTHRODESIS ANTERIOR INTERBODY, INCLUDING DISC SPACE PREPARATION,DISCECTOMY, OSTEOPHYTECTOMY AND DECOMPRESSION OF SPINAL CORD AND/OR NERVE ROOTS [22551 (CPT®)J, BILATERAL SPINE CERVICAL BELOW C2, ARTHRODESIS, ANTERIOR INTERBODY, INCLUDING DISC SPACE PREPARATION, DISCECTOMY, OSTEOPHYTECTOMY AND DECOMPRESSION OF SPINAL CORD AND/OR NERVE ROOTS, EACH ADDITIONAL INTERSPACE [22552 (CPT®)]. SPINE, ANTERIOR INSTRUMENTATION; 4 TO 7 VERTEBRAL SEGMENTS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) [22846 (CPT®)]. WHAT PROBLEM DID-THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706990 LEICA MICROSCOPE DRAPE DRAPE, SURGICAL HRM PHAMASEPT LTD. MEDICAL PRODUCTS 9228H 9126490313

    Patients

    Seq Age Sex Outcome Treatment
    1