BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1925892 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07098
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE TROCARS WERE LEAKING A SEVERE AMOUNT OF GAS. THE PATIENT WAS INSUFFLATED WITH APPROX 500 LITERS OF GAS. UNFORTUNATELY, THE TROCARS USED HAVE BEEN DISCARDED. THE CONSEQUENCE OF THE LEAKAGE IS THAT THE SURGICAL FIELD WAS COMPROMISED AS IT WAS DIFFICULT TO OPERATE AND THE PROCEDURE TOOK LONGER DUE TO THIS PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4U51R

    Patients

    Seq Age Sex Outcome Treatment
    1