BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR

    MDR report key: 2990027 · Received March 5, 2013

    Report

    Report Number
    3005075853-2013-01037
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 11, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). WHAT COLOR LOAD WAS USED? UNKNOWN. HOW INFLAMED WAS THE TISSUE? UNKNOWN. DID THE PATIENT HAVE OTHER CO-MORBID CONDITIONS? NO. CAN YOU PROVIDE PATHOLOGY SHOWING SEVERITY OF DISEASE AND HEALTH OF PROXIMAL MARGIN? NO. SCHEDULED OR EMERGENCY? UNKNOWN. HOW MANY FIRING? TWO. WAS THE HOLE AT THE CECUM, PROVIDE SPECIFIC LOCATION? I WAS TOLD IN THE MIDDLE OF THE STAPLE LINE. WHAT FIRING OCCURRED BEFORE AND AFTER? NOTHING NOTED. DOES THE SURGEON WAIT 15SECS PRIOR TO FIRING? UNKNOWN. HOW DID THE PATIENT PRESENT WHEN RETURNED TO THE ER? ILL WITH FEVER. HOW WAS THE LEAK DETERMINED? VISUAL INSPECTION. WHAT DID THE STAPLE FORM LOOK LIKE AT THE REOPERATION? UNKNOWN. WAS THE REOPERATION OPEN OR LAPAROSCOPIC? LAP. WHAT WAS PERFORMED TO CORRECT THE HOLE? UNKNOWN. HOW IS THE PATIENT CURRENTLY? UNKNOWN. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. PATIENTS AGE, SEX AND WEIGHT? UNKNOWN. I PROVIDED ALL THE INFORMATION I WAS GIVEN BY THE DOCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC APPENDECTOMY PROCEDURE, A WEEK AFTER PROCEDURE, THE PATIENT WENT TO ER WITH PAIN. UPON INSPECTION, IT WAS NOTED BY THE SURGEON THERE WAS A HOLE IN THE MID-STAPLE LINE CAUSING BOWEL CONTENTS TO LEAK. THE PATIENT IS IN HOSPITAL UNDER PHYSICIAN CARE. UNKNOWN HOW CASE WAS COMPLETED. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94267 ETS FLEX ARTICNG LNR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention