BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 2854937 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05435
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT INDICATED THAT THERE WAS DAMAGE LIKE A HOLE OR RIP IN THE TYVEK. THE SALES UNIT WAS RETURNED WITH (B)(4) SEALED PACKAGES. THE CARTON HAD SLIGHT CRUSH/COMPRESSION DAMAGE THAT WAS VISIBLE ON ALL SIDES OF THE CARTON. EACH PACKAGE INSIDE THE CARTON WAS VISUALLY INSPECTED. ON VISUAL INSPECTION, IT WAS CONFIRMED THAT (B)(4) PACKAGE HAD A SMALL HOLE ALIGNED OVER THE DEVICE KNOB FIN. ONE OF THE OTHER PACKAGES HAD A SMALL DENT, OR THIN SPOT ON THE PACKAGE, AND THE REMAINING (B)(4) PACKAGES EXHIBITED NO DAMAGE. THE HOLE CHARACTERISTICS APPEAR INDICATIVE OF DAMAGE CAUSED FROM THE INSIDE OF THE PACKAGE OUTWARDS RATHER THAN DAMAGE THAT WAS CAUSED FROM THE OUTSIDE-INTO THE PACKAGE. WHEN SEEN UNDER MAGNIFICATION, IT WAS OBSERVED THAT THE EDGES OF THE HOLE WERE RAGGED INDICATING THE DAMAGE WAS A TEAR OR SEPARATION OF THE TYVEK FIBERS RATHER THAN A CUT ON THE PACKAGE. IN THE CARTON ORIENTATION RECEIVED, THE DAMAGED PACKAGE WAS THE PACKAGE CLOSEST TO THE CRUSHED/COMPRESSED SIDE OF THE SALES UNIT CARTON; HOWEVER, IT IS NOT POSSIBLE TO DETERMINE IF THE ORIENTATION HAS BEEN THE SAME THROUGHOUT THE LIFE OF THE SALES UNIT CARTON (I.E. FROM ORIGINAL PACKOUT IN ALB THROUGH JJKK INSPECTION AND BACK TO ALB FOR ANALYSIS). FURTHERMORE, IT DOES NOT APPEAR THAT THERE IS AN ORIENTATION OF THE PACKAGE INSIDE THE CARTON THAT WOULD HAVE FACILITATED CONTACT BETWEEN THE AREA WHERE THE PACKAGE WAS DAMAGED AND THE CENTER OF THE CRUSH DAMAGE ON THE CARTON. THE INSIDE OF THE CARTON WAS EXAMINED, BUT NO MARKINGS WERE OBSERVED THAT MIGHT INDICATE SUSTAINED CONTACT WITH THE SURFACE OF THE DAMAGED PACKAGE OVER THE DEVICE KNOB FIN AREA. THE CAUSE OR ORIGIN OF THE HOLE CANNOT BE DETERMINED. LOT HISTORY RECORDS FOR THE DEVICE WERE REVIEWED. NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE AFFILIATE RECEIVED THE PRODUCT(S) AND DURING VISUAL INCOMING OPERATION AND FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS DAMAGE LIKE A HOLE OR RIP ON TYVEK IN A PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGERY PROBE PLUS II LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4CJ5E

    Patients

    Seq Age Sex Outcome Treatment
    1