BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    MDR report key: 1901010 · Received November 17, 2010

    Report

    Report Number
    3005075853-2010-06570
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SALES UNIT CARTON WAS RETURNED WITH SIX INDIVIDUAL PACKAGES. CARTON SHOWED EVIDENCE OF CRUSH/IMPACT DAMAGE AND CARTON LID HAD BEEN TORN OFF. PACKAGES WERE REMOVED FROM THE SALES UNIT CARTON FOR EVALUATION AND EACH WAS NUMBERED 1-6. PACKAGE #1 DEVICE NOT FITTED INTO SNAP FITS CAUSING TYVEK TO EXTEND PAST FLANGE PLANE. THERE WAS NO DAMAGE TO TYVEK OR BLISTER. THERE IS EVIDENCE OF SEAL ON THE TYVEK AND BLISTER; PACKAGE HAD BEEN OPENED AT ONE CORNER. PACKAGE #2 DEVICE NOT FITTED INTO SNAP FITS CAUSING TYVEK TO EXTEND PAST FLANGE PLANE. TIP OF DEVICE PUNCTURED A HOLE THROUGH THE TYVEK. THE PUNCTURE WAS CAUSED BY THE DEVICE BEING OUT OF PLACE INSIDE THE BLISTER PACKAGE. PACKAGE #3 DEVICE NOT FITTED INTO SNAP FITS. THE END OF THE BLISTER PACKAGE WAS BROKEN. FRAGMENTS OF BLISTER FLANGE WERE STILL ADHERED TO THE TYVEK INDICATING THAT PACKAGE WAS SEALED PRIOR TO THE OCCURRENCE OF DAMAGE. THERE IS EVIDENCE OF SEAL ON THE TYVEK AND BLISTER. PACKAGE #4 DEVICE NOT FITTED INTO SNAP FITS. THERE WAS A HOLE IN THE TYVEK OVER THE FIN OF THE DEVICE KNOB. THE HOLE WAS MOST LIKELY CAUSED BY THE DEVICE BEING OUT OF PLACE INSIDE THE BLISTER PACKAGE. THE END OF THE CARTON HAD A BROKEN BLISTER FLANGE. THERE IS EVIDENCE OF SEAL ON THE TYVEK AND BLISTER. PACKAGE #5 DEVICE NOT FITTED INTO SNAP FITS. THERE WAS A LARGE RIP IN THE TYVEK. DAMAGE CAME FROM THE OUTSIDE IN AND DAMAGE IS DIRECTIONAL INDICATING THAT DAMAGE WAS INFLICTED FROM OUTSIDE OF THE PACKAGE AT THE SAME ANGLE AS DAMAGE ON OTHER PACKAGES. PACKAGE #6 DEVICE NOT FITTED INTO SNAP FITS. TYVEK AND BLISTER WERE FINE WITH NO DEFECTS. ALL PACKAGES APPEAR TO HAVE BEEN DAMAGED BY SIGNIFICANT CRUSH OR IMPACT OCCURRING OUTSIDE OF EES PACKAGING. SIGNIFICANT IMPACT FORCE IS REQUIRED TO KNOCK THE DEVICES OUT OF THEIR SNAP FITS IN THE BLISTER. DUE TO THE CONDITION OF THE PACKAGES AND THE SALES UNIT CARTON AND THE FACTS OUTLINED ABOVE, IT IS MOST PROBABLE THAT THE DAMAGE OCCURRED OUTSIDE OF THE EES PACKAGING FACILITY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 226 MG/DL AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED. PRIOR TO THE EVENT, THE INSULIN PUMP ALARMED NO DELIVERY. NOTHING FURTHER WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE FIVE BOXES OF DEVICES LOOKED ORIGINALLY PACKED (THE LOCKING LATCH OF THE OUTER BOX WAS NOT TOUCHED). BUT WHEN THE NURSE OPENED IT, IN ONE OF THE BOXES: ONE STERILITY FOLDER HAS A HOLE IN THE MIDDLE; IT LOOKED LIKE SOMEONE PIERCED IT. FOUR STERILITY FOLDERS WERE OPENED A LITTLE BIT, SO THAT THE INSTRUMENTS WERE NO MORE STERILE. ONE STERILITY FOLDER LOOKED LIKE THAT SOMEONE TRIED TO OPEN IT. THE OTHER STERILITY FOLDER IN THE OTHER FOUR BOXES WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK E4L97

    Patients

    Seq Age Sex Outcome Treatment
    1