BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH-BLADE SCISSORS, DISPOSABLE

    MDR report key: 1345129 · Received February 4, 2009

    Report

    Report Number
    1423507-2009-00022
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Date of Event
    December 22, 2008
    Report Date
    February 4, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED FOR EVAL; THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE ISSUE REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT REPORTED DID NOT IDENTIFY ANY ISSUES WITH THIS PARTICULAR LOT. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS INCIDENT. IF MORE INFO IS LEARNED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, REUSABLE LAPAROSCOPIC SCISSORS WITH A DISPOSABLE SCISSOR TIP WAS USED. THE SECOND TIME THE DOCTOR ATTEMPTED TO USE THE SCISSORS, SHE NOTED THE TIP WAS NOT ON THE INSTRUMENT. SHE SEARCHED WITH THE LAPAROSCOPE AND FOUND THE SCISSOR TIP IN THE ABDOMEN. IT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWITCH-BLADE SCISSORS, DISPOSABLE SCISSORS LRW CARDINAL HEALTH 89-5100B 812502

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR