BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIP 24 AND ZIP 8I SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 6985849 · Received October 27, 2017

    Report

    Report Number
    3009673389-2017-00009
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 27, 2017
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NEITHER THE DEVICE NOR PHOTOGRAPHIC IMAGES WERE PROVIDED, IT IS IMPOSSIBLE TO CONFIRM THE COMPLAINT WITH ABSOLUTE CERTAINTY. PER INFORMATION PROVIDED BY THE PHYSICIAN, "THE ADHESIVE IS NOT HOLDING IF THERE IS DRAINAGE FROM THE WOUND. ONCE IT GETS WET, IT STARTS TO COME OFF." BASED UPON THE PHYSICIAN ASSESSMENT, IT IS ASSUMED THAT THE ZIP DEVICES SUFFERED ADHESION LOSS AS A RESULT TO EXPOSURE TO SIGNIFICANT BODY FLUIDS (I.E., EXUDATE AND/OR BLOOD). THE ZIP PRODUCT INSTRUCTIONS FOR USE STATE "SKIN SHOULD BE CLEAN, DRY AND FREE OF EXUDATE, SKIN OILS, EXCESS PREP RESIDUE OR HAIR FOR ADEQUATE ADHESION" AND CONTRAINDICATES USE OF THE DEVICE "WHERE ADHESION CANNOT BE OBTAINED." THEREFORE, LOSS OF ADHESION IN THE PRESENCE OF EXCESS FLUIDS IS A KNOWN INHERENT RISK DOCUMENTED IN THE IFU AND THE DEVICES APPEAR TO HAVE BEEN SUBJECTED TO CONDITIONS THAT ARE KNOWN TO CAUSE PERFORMANCE ISSUES.

    Description of Event or Problem · 1

    SURGICAL RESIDENT PLACED A ZIPLINE ZIP 8I AND A ZIP 24 FOR CLOSURE OF INCISION(S) CREATED FOR A TRANSPEDICULAR DECOMPRESSION OF EPIDURAL TUMOR HARDWARE EXTENSION PROCEDURE. THE PHYSICIAN SUBSEQUENTLY REPORTED THAT, ON POD 1, THE ZIP DEVICES "FELL OFF". THE DISTRIBUTOR SALES REPRESENTATIVE WHO CONTACTED ZIPLINE REGARDING THE COMPLAINT INDICATED THAT BOTH ZIP DEVICES WERE REMOVED AND CLOSURE WAS ACHIEVED WITH STAPLES. NO ADDITIONAL INTERVENTION OR FURTHER COMPLICATIONS WERE REPORTED AFTER CLOSURE WITH STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763254 ZIP 24 AND ZIP 8I SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS2080 AND PS1240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention