BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1881592 · Received October 25, 2010

    Report

    Report Number
    1527736-2010-00080
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 29, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THERE WAS LEAKAGE. THOUGH THE INSUFFLATION WAS DONE NORMALLY AFTER PLACING THE TROCAR, LEAKS OF SURGICAL GAS ARE NOTICED WHILE INTRODUCING SURGICAL INSTRUMENTS, ESPECIALLY WITH THE 5 MM DIAMETER INSTRUMENTS. THE PROBLEM COULDN'T BE SOLVED DESPITE TWO CHANGES OF THE TROCAR SLEEVE. THE PROCEDURE WAS COMPLETED DESPITE THE DIFFICULTIES EXPERIENCED AND WASTE OF SURGICAL GAS. 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, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1