BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 3013536 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01331
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL COMMENTS: WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSECTION? ASKU. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? ASKU. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? UNKNOWN. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? UNKNOWN. WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? UNKNOWN. WAS BUTTRESSING MATERIAL UTILIZED? UNKNOWN. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED? UNKNOWN. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? COMPLETE BEAUTIFUL DONUTS WHAT IS THE PATIENT'S AGE AND SEX? ASKU. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING AN OPEN LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE FIRED AS INTENDED HOWEVER THE STAPLES DID NOT CLOSE. HAND SEWING WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED. THE POST OP CARE OF THE PATIENT WAS NOT CHANGED DUE TO THE PROLONGED SURGERY. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115336 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H44Z1G

    Patients

    Seq Age Sex Outcome Treatment
    1