BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM LENG

    MDR report key: 1083049 · Received July 24, 2008

    Report

    Report Number
    1527736-2008-03883
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT B: EXP DATE: 02/05/2012; MFR DATE: 03/05/2007. INSTRUMENT C AND D: EXP DATE: 03/01/2013; MFR DATE: 04/01/2008. LEAKED, FRACTURED CLEAR LENS. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT A WAS LEAK TESTED AND FAILED. ADDITIONALLY THE LENS OF THE OBTURATOR WAS NOTED TO BE CRACKED. NO ANOMALIES WERE NOTED WITH THE UNIVERSAL SEAL ASSEMBLY, IT WAS NOTED TO BE PROPERLY ASSEMBLED. THE ANALYSIS RES ULTS FOUND THAT THE INSTRUMENT B WAS FUNCTIONALLY LEAK TESTED AND FAILED. ADDITIONALLY THE LENS OF THE OBTURATOR WAS NOTED TO BE CRACKED. NO ANOMALIES WERE NOTED WITH THE UNIVERSAL SEAL ASSEMBLY, IT WAS NOTED TO BE PROPERLY ASSEMBLED. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT C WAS FUNCTIONALLY LEAK TESTED AND FAILED. ADDITIONALLY THE LENS OF THE OBTURATOR WAS NOTED TO BE CRACKED. NO ANOMALIES WERE NOTED WITH THE UNIVERSAL SEAL ASSEMBLY, IT WAS NOTED TO BE PROPERLY ASSEMBLED. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT D WAS FUNCTIONALLY LEAK TESTED AND FAILED. ADDITIONALLY THE LENS OF THE OBTURATOR WAS NOTED TO BE CRACKED. NO ANOMALIES WERE NOTED WITH THE UNIVERSAL SEAL ASSEMBLY, IT WAS NOTED TO BE PROPERLY ASSEMBLED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAP GASTRIC BYPASS SURGERY THERE WERE 5 TROCARS USED THAT LEAKED DURING THE CASE. THEY WERE SEPARATED FROM WHERE THE HOUSING IS ATTACHED TO THE CANNULA. THEY WERE ABLE TO COMPLETE THE CASE WITH THE 5TH TROCAR WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM LENG GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1