BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOAD FOR 60MM

    MDR report key: 2931573 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00338
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE, DAMAGED DRIVERS, DAMAGED ONE PIECE SLED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? UNKNOWN. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNKNOWN. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? UNKNOWN. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? UNKNOWN. WHAT COLOR CARTRIDGE WAS BEING USED? ECR60T. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNKNOWN. WAS BUTTRESSING MATERIAL UTILIZED? UNKNOWN. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? UNKNOWN. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? UNKNOWN. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? UNKNOWN. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? UNKNOWN. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? UNKNOWN. THE ANALYSIS FOUND THAT ONE RELOAD WAS RECEIVED WITH THE CARTRIDGE BODY, ONE PIECE SLED, AND SOME DRIVERS DAMAGED. IN ADDITION, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED AND LEFT SIDE WITH ONLY THE OUTER ROW FIRED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE RELOAD MISFIRED. ONE SIDE OF THE STAPLE LINE DID NOT CLAMP, THE STAPLES DID NOT MAKE A CROWN SHAPE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37525 RELOAD FOR 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CR2H

    Patients

    Seq Age Sex Outcome Treatment
    1