BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7141153 · Received December 21, 2017

    Report

    Report Number
    2647580-2017-09113
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    August 31, 2017
    Report Date
    August 28, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523002973
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL EXAMINATION OF THE LOADING UNIT NOTED THAT IT WAS PRE-FIRED AND ENGAGED IN INTERLOCK WITH THE JAWS CLAMPED. THIS INDICATED THAT THE JAWS DID NOT OPEN WHEN THE INSTRUMENT RETURN KNOBS WERE RETRACTED. THIS PROVIDED EVIDENCE THAT THE LOADING UNIT WAS NOT ENGAGED PROPERLY DURING LOADING. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. STAPLE PRE-FIRE AND/OR INABILITY TO OPEN THE JAWS AFTER CLAMPING MAY OCCUR UNDER THE FOLLOWING CONDITIONS. 1. THE SHIPPING WEDGE HAS BEEN REMOVED OR IS NO LONGER FULLY SEATED IN THE METAL CHANNEL PRIOR TO LOADING. 2. THE SHIPPING WEDGE HAS BEEN REMOVED OR IS NO LONGER FULLY SEATED IN THE METAL CHANNEL AND THE JAWS HAVE BEEN MANUALLY CLAMPED PRIOR TO LOADING. 3. THE SHIPPING WEDGE HAS BEEN REMOVED OR IS NO LONGER FULLY SEATED IN THE METAL CHANNEL AND AN ATTEMPT HAS BEEN MADE TO LOAD A LOADING UNIT WITH THE INSTRUMENT FIRING ROD EXTENDED. PLEASE NOTE THAT THE YELLOW SHIPPING WEDGE MUST BE SECURELY IN PLACE DURING INSTRUMENT LOADING. THE SHIPPING WEDGE ENSURES THAT THE SINGLE-USE LOADING UNIT (SULU) ENGAGES IN THE INSTRUMENT TO FACILITATE CLAMPING AND UNCLAMPING. SECTION 2 IN THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES EACH PRODUCT SHIPMENT, CAUTIONS THE USER CAUTION: DO NOT ATTEMPT TO REMOVE THE SHIPPING WEDGE UNTIL THE SINGLE-USE LOADING UNIT (SULU) IS LOADED INTO THE INSTRUMENT. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE LOAD DID NOT OPEN, REQUIRING THE USE OF TWO LOADS, ONE BEFORE AND ONE AFTER. THE STAPLER DID NOT WORK AFTER USING THE DEFECTIVE LOAD. THEY OPENED ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919043 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 030422 P3F0263X 10884523002973

    Patients

    Seq Age Sex Outcome Treatment
    1