BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON GENISTRONG RETRIEVAL BAG, XL

    MDR report key: 10378827 · Received August 7, 2020

    Report

    Report Number
    3002590791-2020-00058
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    September 19, 2019
    Report Date
    August 14, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED (DATE OF EVENT), UPDATED (DATE OF THIS REPORT), (UDI), (FOLLOW UP 001), (CORRECTION).

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES BETWEEN OCTOBER 2017 THROUGH DECEMBER 2019. THE DEVICE WAS NOT RETURNED TO GENICON, INC.

    Description of Event or Problem · 1

    "TODAY, ONE OF THE SAMPLES FOR REF # (B)(4) WAS TRIED BECAUSE IT IS A BIGGER BAG. SUBSEQUENTLY, THERE ARE SOME MAJOR CONCERNS RELATED TO THE DESIGN, AND EVEN MORE CONCERNING, THE QUALITY OF THE PRODUCT. THE BAG COMPLETELY TORE OFF FROM THE STRING. THE BAG AND THE SPECIMEN HAD TO BE RETRIEVED. THE TAPERED OR SEMICIRCULAR CUT OF THE DISTAL PORTION OF THE BAG IS NOT USEFUL. THE OPENING ISN'T LARGE ENOUGH TO ADEQUATELY ACCOMMODATE THE SPECIMENS. THEREFORE, PURELY AS A PATIENT SAFETY ISSUE RELATED TO THE COMPLETE FAILURE OF THIS ITEM AND THE OVERALL LACK OF UTILITY WITH THE OTHER RETRIEVER SIZES, WE WILL NOT BE ORDERING ANY MORE OF THESE ITEMS IN THE FORESEEABLE FUTURE. AS FAR AS I CAN TELL, THE LOT NUMBER INVOLVED IS 19614-G. UNFORTUNATELY, THE DEFECTIVE UNIT WAS TOSSED IN THE TRASH AND IS UNAVAILABLE." PER EMAIL FROM (B)(6) - PMI SALES REP: "GOOD AFTERNOON. HERE IS THE INFO I KNOW. PRODUCT INFORMATION: WAS THIS A SINGLE USE DEVICE THAT HAD BEEN REPROCESSED? NEW STERILE SAMPLE. EVENT INFORMATION: WAS THERE A PATIENT INJURY? IF YES, WHAT IS STATUS OF PATIENT NOW? NO. WAS THERE A DELAY IN PROCEDURE? YES, SINCE THEY HAD TO RETRIEVE BAG, AS INDICATED IN PER. IF YES, DID THE DELAY IMPACT PATIENT SAFETY? NO. HOW WAS THE PROCEDURE COMPLETED? (I.E. ANOTHER GENICON UNIT OR A COMPETITOR'S PRODUCT)THEY FISHED THE BAG OUT. CAN YOU PROVIDE ANY MORE DETAIL ON THE INCIDENT ITSELF? WHAT TYPE OF PROCEDURE, SPECIMEN, ETC. WHAT OTHER DEVICES WERE BEING USED. DID THE SURGEON ENLARGE THE SITE, HOW LARGE WAS THE PORT SITE? UNKNOWN. HAS THE SURGEON USED OUR PRODUCTS BEFORE? NO. IF NO, WAS IN-SERVICE PROVIDED PRIOR TO THE CASE? YES, BY THE CRD. I WAS IN (B)(6) ON A DIFFERENT GENICON EVALUATION. THIS IS ANY ADDITIONAL INFO I HAVE THAT MAY OR MAY NOT HAVE BEEN COVERED IN THE PER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842041 GENICON GENISTRONG RETRIEVAL BAG, XL SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-008 I9614-G

    Patients

    Seq Age Sex Outcome Treatment
    1