BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS MED

    MDR report key: 1890341 · Received November 3, 2010

    Report

    Report Number
    3005075853-2010-06282
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TORN RETRACTOR SHEATH. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE RETRACTOR SHEATH TORN. THE TEAR INITIATED 2 INCHES BELOW THE UPPER RETRACTOR RING AND CONTINUED TOWARD THE LOWER RETRACTOR RING. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION RECEIVED SUGGESTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE DUE TO WEAR, OSTEOLYSIS AND LOOSENING OF THE ACETABULAR CUP. REVIEW OF RADIOGRAPHS AND INVOICE HISTORY REVEALED THAT THE PATIENT UNDERWENT A PRIOR REVISION PROCEDURE ON (B)(6) 2008 FOR AN UNKNOWN REASON. SUBSEQUENTLY, PATIENT WAS REVISED AGAIN ON (B)(6) 2009. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    WHILE PERFORMING A FUNCTION CHECK, THE TECHNICIAN OBSERVED THAT THE RIGHT HEAD SIDERAIL LATCH WAS NOT ALWAYS LATCHING INTO PLACE WHEN RAISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, THEY WERE TRYING TO PUT THE DEVICE INSIDE WHEN THEY DISCOVERED THAT THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS MED LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4TC9E

    Patients

    Seq Age Sex Outcome Treatment
    1