BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 59004 · Received December 18, 1996

    Report

    Report Number
    1527736-1996-00690
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Report Date
    December 17, 1996
    Manufacturer
    ETHIENDOSURG ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING LAPAROSCOPIC ASSISTED VAGINAL. DURING THE BURCH PORTION OF THE PROCEDURE, THE EMS JAMMED AFTER FIRING APPROX FOUR STAPLES INTO THE PERIVAGINAL TISSUE. A SECOND EMS WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 11/13/96 1550 DR CONFIRMED THE INFORMATION AS REPORTED BY THE SALES REP. HE STATED AFTER THE FIRST FEW FIRINGS THE STAPLES WERE COMING OUT CROOKED AND WERE NOT FOLDING INTO THE TISSUE THE RIGHT WAY. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE CASE. DR SAID HE HAD TO GO BACK AND RE-STAPLE EVEN THE FIRST FEW SATPLES FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC MULTIFEED STAPLER GAG ETHIENDOSURG ENDO-SURGERY, INC. NA J42CZC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other