BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRA-TY

    MDR report key: 1893448 · Received November 8, 2010

    Report

    Report Number
    3005075853-2010-06374
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE JAWS BENT. DURING ANALYSIS THE CLIPS WERE LOADED ON THE DEVICE BUT ONLY TWO CLIPS COULD NOT BE FIRED ON THE SUTURE DUE THE CONDITION OF THE JAWS. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE DAMAGE FOUND. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE WOULD NOT HOLD AND CLIPS SECURELY IN THE JAW AND CRIMP COMPLETELY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT OF A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE, THE TUBING BECAME DISCONNECTED FROM THE PORT. THIS WAS DETECTED DURING A ROUTINE FILL WITH NO RESTRICTION VIA FLUOROSCOPY. THE LOCKING CONNECTOR WAS ATTACHED TO THE PORT IN THE LOCKED POSITION. THE STRAIN RELIEF WAS FOUND ON THE TUBING FLOATING IN THE ABDOMEN. IT IS UNKNOWN HOW MANY ADJUSTMENTS AND THE AMOUNT. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPRA-TY LAPRA-TYABSORBABLE CLIP APPLIER GDO ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1