BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-L SIDE LOADING RET HAND-AL.

    MDR report key: 8917309 · Received August 21, 2019

    Report

    Report Number
    1923569-2019-00009
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 4, 2019
    Report Date
    October 17, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    GZT
    PMA / PMN Number
    K964402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): THIS EVENT WAS INADVERTENTLY REPORTED TO US TWICE. THIS IS A DUPLICATE OF 1923569-2019-00007, PLEASE CANCEL THIS REPORT.

    Description of Event or Problem · 0

    THE SURGEON WAS NOT ABLE TO HOLD THE BLADE BECAUSE THE LOCKING RETRACTOR HANDLE STUCK WHILE TIGHTENING THE HANDLE. THE SURGEON HELD THE BLADE BY HAND AND SET THE RETRACTOR. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL INFORMATION RECEIVED ON 13AUG2019, THE CUSTOMER REPORTED THE SURGEON HELD THE BLADE BY HAND AND SET THE RETRACTOR FOR THE ACDF. IT WAS UNKNOWN: IF THE DEVICE GOT STUCK WHILE THREADING THE BLADE, IF OIL WAS USED TO LUBRICATE METAL ON METAL THREADING, ANY PATIENT INFORMATION, IF THERE WAS ANY PATIENT INJURY, OR IF THE PROCEDURE WAS COMPLETED AS PLANNED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO HOLD THE BLADE BECAUSE THE LOCKING RETRACTOR HANDLE STUCK WHILE TIGHTENING THE HANDLE. THE SURGEON HELD THE BLADE BY HAND AND SET THE RETRACTOR. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL INFORMATION RECEIVED ON 13AUG2019, THE CUSTOMER REPORTED THE SURGEON HELD THE BLADE BY HAND AND SET THE RETRACTOR FOR THE ACDF. IT WAS UNKNOWN: IF THE DEVICE GOT STUCK WHILE THREADING THE BLADE, IF OIL WAS USED TO LUBRICATE METAL ON METAL THREADING, ANY PATIENT INFORMATION, IF THERE WAS ANY PATIENT INJURY, OR IF THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712554 S-L SIDE LOADING RET HAND-AL. RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY GZT CAREFUSION, INC K16

    Patients

    Seq Age Sex Outcome Treatment
    1 Other