BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 2861498 · Received December 7, 2012

    Report

    Report Number
    3005075853-2012-05499
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHAT TYPE OF ANASTOMOSIS WAS CREATED? (END TO END, END TO SIDE) END TO END. WHICH STAPLING TECHNIQUE WAS USED? (SINGLE, DOUBLE OR TRIPLE) SINGLE PURSE STRING. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON?YES. WHO FIRED THE DEVICE?SURGEON. HAS THE PERSON FIRING BEEN TRAINED ON HOW TO USE THE EES CIRCULAR DEVICE? YES. HAS THE O.R. STAFF BEEN TRAINED IN PREPARING THE EES CIRCULAR DEVICE? YES. WHERE WAS THE LEAK (ANASTOMOTIC RING, ANASTOMOTIC RING-TRANSECTION LINE INTERFACE, OTOMY, ETC.)? TRANSECTING LINE. HOW WAS THE LEAK ADDRESSED? SUTURE. WERE THERE STAPLES PRESENT IN THE REPAIR SPOT?YES. WHAT DID THE STAPLE FORM LOOK LIKE?NORMAL. WHAT WAS THE INDICATION FOR SURGERY?DIVERTICULITIS. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS?SAME. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT'S HEALTH/SURGICAL OUTCOME?BAD TISSUE. HAS THE PATIENT UNDERGONE ANY RADIATION OR CHEMO THERAPY? RADIATION. WERE THERE ANY COMORBIDITY CONCERNS (DIABETES, CROHN S, AUTO-IMMUNE DISORDERS, COAGULATION ISSUES, ETC.)?NA. IS THERE ANY ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE RELATIVE TO THE ISSUE?NO. WHAT IS THE PATIENT S PRESENT CONDITION? RECOVERED. WHERE THERE ANY ISSUES WITH THE PSE60A? NO.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED POST OP A LAP LOW ANTERIOR RESECTION PROCEDURE, THERE WAS A LEAK ON POST OP DAY 5. THE DISTAL FIRING WAS WITH THE POWERED ENDOCUTTER, BLUE LOAD AND THE PROXIMAL CUT WAS WITH SCISSORS, TISSUE WAS THICKER BUT HEALTHY. USED HAND SEWN PURSE STRING WITH ANVIL AND COMPLETED FIRING WITH CIRCULAR. THE OPERATIVE RECTAL STUMP AND LEAK TEST PERFORMED UNDER WATER WITH NO BUBBLES. THE STAPLES LOOKED INTACT. THE PATIENT BROUGHT BACK IN WITH LEAK REPAIR IN A SPOT ASSUMED TO HAVE BEEN REPAIRED WITH SUTURE. THE PATIENT RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention