BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRA-CUT

    MDR report key: 5440608 · Received February 10, 2016

    Report

    Report Number
    MW5060205
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE TEACHER FELL AT SCHOOL SEVERAL WEEKS AGO, HAD PROGRESSIVE ONSET OF HEADACHES, DIZZINESS AND NAUSEA. CAME TO ED AND FOUND TO HAVE BILATERAL SUBACUTE SUBDURAL HEMATOMAS WITH A SLIGHT SHIFT. HE WAS TAKEN TO OPERATING ROOM FOR DECOMPRESSION. TYPE: OPERATIVE REPORT RESULT DATE: (B)(6) 2016 12:00 MST STAFF: ..., MD. POSTOPERATIVE DIAGNOSIS: BILATERAL SUBACUTE SUBDURAL HEMATOMA. PROCEDURE: BILATERAL BURR HOLES WITH PLACEMENT OF THE SUBDURAL DRAIN. AFTER A SUITABLE PREP AND DRAPE, A LINEAR INCISION WAS MADE OVER THE INFILTRATION WITH MARCAINE. THE INCISION WAS TAKEN DOWN TO THE PERICRANIUM AND THE PERICRANIUM SWEPT ON EITHER SIDE. WE ATTEMPTED A BURR HOLE ON THE LEFT-HAND SIDE, BUT HAD DIFFICULTY DUE TO A MECHANICAL PROBLEM WITH THE BURR. ULTIMATELY, WE HAD TO DRILL THIS DOWN USING AN AM-8. ONCE WE HAD THE APPROPRIATELY SIZED HOLE ON THE LEFT-HAND SIDE, WE THEN COAGULATED THE DURA. THE SIMILAR PROCEDURE WAS THEN CARRIED OUT ON THE RIGHT-HAND SIDE. PER OPERATING ROOM NURSE: DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM WITH THE LOT NUMBER 9055 EXPIRES (B)(6) 2025. FOUR OF THESE ITEMS WERE USED IN CRANIUM BURR HOLES SURGERY PERFORMED BY DR...., NEUROSURGEON. WHEN THE FIRST ONE WAS OPENED, DR. ... NOTICED THAT THE ITEM BROKE WHEN USED SO HE ASKED FOR A SECOND CRANIAL PERFORATOR. WHEN THE SECOND CRANIAL PERFORATOR WAS OPENED AND USED, DR. ... TOLD THE SURGICAL TECH THAT THE ITEM WAS NOT POWERFUL AND NOT STOPPING SO HE ASKED FOR A THIRD CRANIAL PERFORATOR, SAME THING HAPPENED. IT DID NOT STOP. PT WAS STABLE AND NO COMPLICATIONS NOTED. DID NOT GO THROUGH DURA. PT DISCHARGED HOME STABLE. BITS ARE AVAILABLE FOR VENDOR TO TAKE. TS/RM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84950 ACRA-CUT DISPOSABLE CRANIAL PERFORATOR HBE ACRA-CUT, INC. 9055

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention