BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS - ENDOSCOPIC LINEAR

    MDR report key: 3022627 · Received March 27, 2013

    Report

    Report Number
    3005075853-2013-01408
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WEDGE BAND BYPASS ADDITIONAL INFORMATION: THE PATIENT IS FINE AND IS DUE TO GO HOME ON THURSDAY (B)(6). FOLLOWING THE OPERATION, HE SPENT 2 DAYS IN ICU. THE PATIENT AND FAMILY HAVE ALL BEEN INFORMED OF THE INCIDENT AND JUST SEEM VERY GRATEFUL FOR REMOVING THE TUMOR. THE PATIENT'S PROGNOSIS IS VERY GOOD. THE FIRST FIRING OF THE ETS35W WAS AS EXPECTED. IT FELT A LITTLE STIFF TO FIRE THE SECOND FIRING . ON RELEASING THE GUN THE BLOOD JUST POURED OUT. THE DR SAID HAD THERE BEEN A SECOND SUCKER AVAILABLE, IT MIGHT HAVE BEEN POSSIBLE TO CLAMP THE VESSELS AND TO AVOID THE NEED FOR FEMORAL BYPASS. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO CLIPS USED - ONE PREVIOUS FIRING BUT STAPLES ON PV NOT NEAR PA. WERE ANY UNEXPECTED NOISES HEARD? NO UNEXPECTED NOISES. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? FORCE TO FIRE WAS HIGHER BUT NOT EXCESSIVE. DID THE SURGEON HAVE PROXIMAL AND DISTAL CONTROL FOR THE FIRING? WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? NO ABNORMAL PRE-EXISTING CONDITIONS DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? OVER 15 YEARS EXPERIENCE WITH DEVICE. HAS THE PATIENT BEEN RELEASED? PATIENT WAS SENT HOME BUT WAS RE-ADMITTED LAST NIGHT. WITH QUERY PLEURAL EFFUSION AND/OR QUERY PULMONARY EMBOLISM THE ANALYSIS RESULTS FOUND THAT THE TSW35 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH TWO RELOADS PRESENT. THE RELOAD (B) WAS FULLY FIRED AND IN GOOD VISUAL CONDITION. THE RELOAD (C) WAS RETURNED PARTIALLY FIRED AND WAS NOTED TO HAVE A WEDGE BAND BYPASS AS THE RIGHT SIDE WAS FULLY FIRED AND THE LEFT SIDE WAS PARTIALLY FIRED 1/4. THE CARTRIDGE LOCKOUT WAS FOUND NORMAL. NO EVIDENCE OF DAMAGE ON DECK WAS NOTED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. IN ADDITION THE RETURNED RELOAD (C) WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE WEDGE SLED AND CARTRIDGE BODY WERE NOTED TO BE DAMAGED. PHOTOGRAPHS WERE REVIEWED. BASED ON THE PHOTOGRAPHIC EVIDENCE IT WAS CONFIRMED "STAPLES WERE ONLY DEPLOYED ON ONE SIDE OF THE CARTRIDGE" PER THE EVENT DESCRIBED IN THE PRODUCT INQUIRY. HOWEVER, THERE WAS NO PHOTOGRAPHIC EVIDENCE IN MY OPINION THAT COULD EXPLAIN THE CAUSE OF THE COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT HAD A MISS FIRE OF THE GUN DURING SURGERY. THE PATIENT HAD TO BE PUT ON BYPASS. THE INCIDENT OCCURRED ON THE SECOND FIRING OF THE DEVICE. THE FIRST FIRING WOULD HAVE BEEN THE PULMONARY VEIN AND ALL WENT AS EXPECTED. THE INCIDENT HAPPENED ON THE NEXT FIRING WHICH WAS ACROSS THE PULMONARY ARTERY. THE GUN WAS FIRED BUT STAPLES WERE ONLY DEPLOYED ON ONE SIDE OF THE CARTRIDGE. THE PATIENT HAD TO BE PUT ON BYPASS AND LOST AROUND 7 LITERS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125058 ETS - ENDOSCOPIC LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention