BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LINEAR CUTTER

    MDR report key: 1780344 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04259
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 2, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: ACCORDING TO THE DICTATION, THE DEVICE FIRED. SINCE THE EVENT OCCURRED ALMOST TWO YEARS AGO, THE ACCOUNT STAFF WAS NOT IN THE CASE AND IT OCCURRED PRIOR TO THEM BEING INVOLVED, THE INFORMATION PROVIDED IS ALL THEY HAD. THEIR ACCOUNT HAS BEEN NOTIFIED THAT AN ATTORNEY IS INVOLVED. THEREFORE, THE DEVICE WILL NOT BE RELEASED; THE EVENT WILL BE GOING TO COURT. ANY FOLLOW-UP SHOULD BE WITH THE ACCOUNT'S CORPORATE ATTORNEY. EES RISK MANAGER: SPOKE WITH THE CORPORATE ATTORNEY REGARDING THIS EVENT. THE PATIENT IS A (B)(6) FEMALE WHO UNDERWENT SURGERY FOR SUSPECTED APPENDICITIS; HOWEVER, ONCE IN THE OPERATING ROOM, AN OVARIAN CYST WAS DETERMINED TO BE THE SOURCE OF PAIN AND WAS REMOVED. THE PATIENT HAD AN ER VISIT TO THIS FACILITY IN LATE (B)(6) 2008 FOR PAIN AND THE DIAGNOSIS WAS PREMENSTRUAL PAIN. THE CARTRIDGE WAS REMOVED ON (B)(6) LAPAROSCOPICALLY AT A DIFFERENT FACILITY. AT THIS TIME, THE EVENTS THAT PRECIPITATED IDENTIFYING AND REMOVING THE CARTRIDGE ARE UNCLEAR SINCE TREATMENT OCCURRED IN A DIFFERENT FACILITY. THE SURGEON HAS RETIRED SINCE 2008 AND ONE OF HIS FORMER PARTNERS PERFORMED THE PROCEDURE TO REMOVE THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4):OP REPORT & (B)(4) 2010, SURG CONSULT & X-RAYS & CT SCAN - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6), 2008. POST-OPERATIVE THE PROCEDURE, THE PATIENT WAS EXPERIENCING ABDOMINAL PAIN AND DISCOMFORT. THE PATIENT WENT BACK TO SEE ANOTHER SURGEON AND THEY SCHEDULED AN X-RAY AND IT SHOWED THE CARTRIDGE FROM THE DEVICE WAS EMBEDDED SUPERFICIALLY INTO THE PATIENT'S ABDOMINAL WALL. ON (B)(6), 2010, THE ABDOMINAL WALL WAS TAKEN DOWN A LITTLE; THE CARTRIDGE WAS THEN REMOVED. IT WAS REMOVED LAPAROSCOPICALLY. THEY INITIALLY ATTEMPTED TO REMOVE THE CARTRIDGE THROUGH THE TROCAR BUT COULD NOT GET IT THROUGH. THE TROCAR WAS THEN REMOVED AND THE CARTRIDGE WAS RETRIEVED LAPAROSCOPICALLY. THE CARTRIDGE REMAINS WITH THE ACCOUNT. IT IS BEING RETAINED FOR LEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention TR35W