BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM

    MDR report key: 1981215 · Received February 8, 2011

    Report

    Report Number
    3005075853-2011-00495
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 18, 2011
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. RECEIVED THE FOLLOWING: THE PATIENT WAS DOING FINE WHEN ASKED. NO LEAK TEST WAS PERFORMED AT THE SITE OF THAT STAPLE LINE. SYMPTOMS AT THE TIME OF RETURN ARE NOT CLEAR/WERE NOT SHARED. THE PATIENT RETURNED APPROXIMATELY ONE WEEK AFTER THE DAY OF SURGERY. UNKNOWN ON HOW THE LEAK WAS REPAIRED AND WHETHER SUBSEQUENT SURGERY WAS NEEDED. NOT CLEAR ON WHICH ABSCESS IS BEING REFERRED TO. UNKNOWN WHETHER A DRAIN WAS LEFT IN. THE PRE OP DIAGNOSIS WAS GASTRIC TUMOR. UNKNOWN WHETHER THE PATIENT HAD EVER EXPERIENCED CHEMOTHERAPY BEFORE. THE QUALITY OF THE TISSUE WAS COMMENSURATE WITH A PATIENT WHO HAS MULTIPLE GASTRIC TUMORS AND ADVANCED IN AGE. PATIENT WAS A FEMALE, (B)(6). STATUS AS OF TODAY IS UNKNOWN, BUT NO FURTHER COMPLAINTS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION PROCEDURE ON (B)(6), 2011, THE DEVICE FIRED FINE AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE DURING THE INITIAL PROCEDURE. TEN DAYS POST-OP, THE PATIENT WAS TAKEN TO THE ER FOR A POST -OP LEAK. IT IS UNKNOWN HOW THE LEAK WAS DETECTED. IT IS UNKNOWN WHAT CAUSED THE LEAK, BUT THE SURGEON STATED THAT THE LEAK OCCURRED ALONG THE DEVICE'S STAPLE LINE. THE PATIENT HAD AN ABSCESS. THE ABSCESS WAS DRAINED AND THE PATIENT IS CURRENTLY BEING MONITORED. THERE IS NO FURTHER INFORMATION RIGHT NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE