BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 16 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 6985843 · Received October 27, 2017

    Report

    Report Number
    3009673389-2017-00008
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 27, 2017
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PRODUCT INSTRUCTIONS FOR USE, "SKIN SHOULD BE CLEAN, DRY AND FREE OF EXUDATE, SKIN OILS, EXCESS PREP RESIDUE OR HAIR FOR ADEQUATE ADHESION." BASED ON INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS "A LOT OF FLUID LEAK THROUGH THE INCISION". SINCE NEITHER THE DEVICE NOR PHOTOGRAPHIC IMAGES WERE PROVIDED, IT IS IMPOSSIBLE TO CONFIRM THE COMPLAINT AND DETERMINE THE CAUSE OF THE FAILURE MODE WITH ABSOLUTE CERTAINTY. IT ALSO UNKNOWN WHETHER THE LEAKAGE RESULTED IN DEVICE MALFUNCTION / FAILURE TO MEET SPECIFICATIONS; HOWEVER, NO MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    SURGICAL RESIDENT PLACED A ZIPLINE ZIP 16 FOR CLOSURE OF AN L4-L5 SPINAL LAMINECTOMY PROCEDURE. THE PHYSICIAN SUBSEQUENTLY REPORTED THAT ON THE DATE OF SURGERY, THERE WAS "A LOT OF FLUID LEAK THROUGH THE INCISION, SO WE HAD TO REMOVE THE ZIP AND PUT IN REGULAR STAPLES." UPON NOTIFICATION OF THE LEAKAGE, THE RESIDENT INTENDED TO REPLACE THE ZIP DEVICE WITH A NEW ZIP; HOWEVER, CHOSE TO CLOSE THE INCISION WITH STAPLES INSTEAD, DUE TO THE AMOUNT OF FLUID LEAKAGE PRESENT. PER THE DISTRIBUTOR SALES REPRESENTATIVE WHO REPORTED THE COMPLAINT TO ZIPLINE MEDICAL, ADDITIONAL INTERVENTION WAS NOT REQUIRED AND NO FURTHER COMPLICATIONS WERE REPORTED AFTER CLOSURE WITH STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763252 ZIP 16 SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1160 1003564-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention