BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTABLE NEW TLC

    MDR report key: 3771081 · Received April 24, 2014

    Report

    Report Number
    3005075853-2014-02799
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED: WHEN WAS THE OPEN ANASTOMOSIS NOTICED? DURING THE FIRST SURGERY? WHEN DID THE RE-OPERATION TOOK PLACE? ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? WHAT COLOR (BLUE/GOLD/GREEN) WAS SELECTED ON THE SELECTABLE STAPLE HEIGHT SELECTOR BEFORE FIRING? DID THE SURGEON MOVE THE FIRING KNOB LEFT AND RIGHT BEFORE FIRING? WAS THE HANDLE CLOSED COMPLETELY BEFORE FIRING? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? DID ANY PART OF THE INSTRUMENT BREAK-OFF FROM THE DEVICE? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? WHAT WERE THE PATIENT¿S PRE-EXISTING CONDITIONS? DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? WHAT PREDICATE DEVICE WAS USED BY THE SURGEON? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? RIGHT OR LEFT HEMICOLECTOMY? HOW WAS THE ANASTOMOSIS CREATED (SIDE TO SIDE,¿)? MESSAGE RECEIVED PER AFFILIATE: UNFORTUNATELY WE DID NOT RECEIVE ANY FURTHER INFORMATION REGARDING THE EVENT YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A HEMICOLECTOMY PROCEDURE, THE ANTERIOR FIELD ANASTOMOSIS GOT OPEN. RE-OPERATION WAS DONE. PATIENT IS NOW WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250094 SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DH4N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention