BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M PRECISE VISTA DISPOSABLE SKIN STAPLER

    MDR report key: 4939615 · Received July 21, 2015

    Report

    Report Number
    2110898-2015-00029
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    April 24, 2015
    Report Date
    July 3, 2015
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT PROVIDED. NO LOT NUMBER WAS PROVIDED. WITHOUT THE LOT NUMBER IT IS NOT POSSIBLE TO DETERMINE THE EXPIRATION DATE OR MANUFACTURE DATE OF THE PRODUCT. THE E-MAIL, PHONE NUMBER, OCCUPATION AND NAME OF THE INITIAL REPORTER FROM HOSPITAL WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL EMPLOYEE REPORTED THAT A 3M PRECISE VISTA DISPOSABLE SKIN STAPLER WAS USED TO SUTURE A WOUND ON THE HEAD OF A (B)(6) MALE. THE EMPLOYEE ALLEGED THAT THE STAPLER HANDLE DID NOT RETURN AFTER FIRING THE FIRST STAPLE. THE STAPLE DID NOT DETACH FROM THE PATIENT'S HEAD. THE STAPLE WAS BENT AND BY USING FORCEPS, THE STAPLE HAD TO BE REMOVED. THE PATIENT'S WOUND WAS ALLEGEDLY WIDENED AS A RESULT OF THIS PROCEDURE. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE THIS INCIDENT WAS ATTRIBUTED TO FAILURE TO FOLLOW THE INSTRUCTIONS APPLICABLE FOR THIS PRODUCT. THE IFU STATES UNDER CONTRAINDICATIONS; "WHEN IT IS NOT POSSIBLE TO MAINTAIN AT LEAST 5 MM DISTANCE FROM THE STAPLED SKIN TO UNDERLYING STRUCTURES THE USE OF STAPLERS FOR SKIN CLOSURE IS CONTRAINDICATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471796 3M PRECISE VISTA DISPOSABLE SKIN STAPLER REMOVABLE SKIN STAPLE KKX 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other NONE SPECIFIED.