BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE ENDO GIA 30-2.5

    MDR report key: 63334 · Received January 3, 1997

    Report

    Report Number
    1219161-1997-00006
    Event Type
    Malfunction
    Date Received
    January 3, 1997
    Date of Event
    November 25, 1996
    Report Date
    December 4, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1/10/97 - SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE EVALUATION INDICATED AND CODES ENTERED IN H3 AND H6. ADDITIONAL DATA ENTERED IN D9. THE CLINICALLY APPLIED STAPLER WAS RETURNED NDN EVALUATED. DAMAGE WAS OBSERVED TO THE GEAR HANDLE TEETH. CO CANNOT RELIABLY DETERMINE THE EXACT CAUSE OF THIS DIFFICULTY REPORTED OR THE DAMAGE OBSERVED AS THE CLINICALLY APPLIED DISPOSABLE LOADING UNIT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO GIA 30-2.5 DISPOSABLE STAPLER GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN