BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLECYSTECTOMY TRAY

    MDR report key: 5724174 · Received June 14, 2016

    Report

    Report Number
    1527736-2016-00016
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    May 24, 2016
    Report Date
    May 25, 2016
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    PKE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE SENT: 6/14/2016 ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 6/27/2016. THE DEVICES FROM THE FNC42XL WERE RETURNED FOR ANALYSIS. THE PRIMARY PACKAGE WAS NOT RECEIVED FOR ANALYSIS. WE WERE UNABLE TO EVALUATE THE REPORTED CONDITION AS THE FNC42XL PACKAGE WAS NOT RETURNED FOR ANALYSIS. IT COULD NOT BE DETERMINE WHAT MAY HAVE CAUSE THE REPORTED EVENT. THE LOT HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE DURING STOCK CHECK, THE LAP-CHOLE TRAY (STERILE PACKED) WAS FOUND TO BE UNSTERILE WITH COMPROMISED INTEGRITY OF OUTER PLASTIC COVER. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376833 CHOLECYSTECTOMY TRAY CHOLECYSTECTOMY TRAY PKE ETHICON ENDO SURGERY, INC (CINCINNATI) NA M9325U

    Patients

    Seq Age Sex Outcome Treatment
    1