BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1843060 · Received September 23, 2010

    Report

    Report Number
    3005075853-2010-05485
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: DURING THE INITIAL PROCEDURE, IT WAS BELIEVED THAT THE STAPLE LINE UNZIPPED DUE TO THE BOWEL SIZER BEING INTRODUCED BUT ACTUALLY IT WAS DUE TO MALFORMED STAPLE AT THE DISTAL END OF THE STAPLE LINE. IT WAS THE SURGEON'S CHOICE TO HAND SUTURE THE STAPLE LINE DUE TO THE ANASTAMOSIS BEING SO LOW IN THE PELVIS. THE PATIENT HAD RECEIVED SIX UNITS OF BLOOD SINCE THE PROCEDURE. THE SURGEON TOOK THE PATIENT BACK INTO THE OR TO CHECK THE STAPLE LINE AND ANASTAMOSIS TO SEE IF THEY WERE STILL INTACT. THE STAPLE LINE AND THE ANASTAMOSIS WERE INTACT AND THERE WERE NO BLEEDERS DETECTED. THERE WAS OLD BLOOD FROM THE SACRUM AND THE POSTERIOR MESENTERY THAT WAS SUCTIONED OUT. THE SURGEON STATED THE PATIENT WAS NOT TAKEN BACK INTO THE OR BECAUSE OF A MALFUNCTION OF THE DEVICE. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW OF ADDITIONAL INFORMATION RECEIVED "[SURGEON] NOTICED THE BLEEDING WAS FROM THE SACRUM - NOWHERE NEAR WHERE THE CONTOUR WAS FIRED," IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR AN ADVERSE EVENT. ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE RECEIVED: DID THE SURGEON HAVE ANY ISSUES FIRING THE DEVICE? NO. HOW MANY TIMES WAS THE DEVICE FIRED?ONCE. WHAT COLOR RELOAD(S) WERE USED?BLUE WHERE THE DEVICE WAS FIRED? SIGMOID. HOW LONG POST-OPERATIVELY WAS THE PATIENT TAKEN BACK TO THE OR? 2-3 DAYS. IF INITIALLY THE SURGEON DID NOT KNOW WHY THE STAPLE LINE UNZIPPED, BUT THEN DETERMINED THAT THERE WERE MALFORMED STAPLES AT THE DISTAL END AND THE REOPERATION WAS TO CHECK THE STAPLE LINE, WHY DID THE SURGEON COMMENT THAT THE PATIENT WAS NOT TAKEN BACK DUE TO THE DEVICE? SURGEON INSPECTED THE ANASTAMOSIS AND EVERYTHING WAS INTACT. HE NOTICED THE BLEEDING WAS FROM THE SACRUM - NOWHERE NEAR WHERE THE CONTOUR WAS FIRED. WHY WAS THE PATIENT GIVEN SIX UNITS OF BLOOD? HE LOST BLOOD. WHEN WAS THE PATIENT GIVEN THE BLOOD? HOW LONG POST-OPERATIVELY? UNK. DO YOU KNOW HOW MUCH BLOOD THE PATIENT LOST? UNK. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? CANCER. DID THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION? NO. WHAT ARE THE PATIENT'S AGE AND SEX? M/(B)(6). WHAT IS THE CURRENT STATUS OF THE PATIENT? DISCHARGED HOME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR PERITONEUM RESECTION PROCEDURE, THE STAPLE LINE UNZIPPED WHEN THE BOWEL SIZER WAS INTRODUCED. IT IS UNKNOWN WHY THE STAPLE LINE UNZIPPED. THE PATIENT HAS HAD CHEMO TREATMENTS AND THERE MAY HAVE BEEN AN ISSUE WITH THE TISSUE. SUTURES WERE USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE