BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 1840135 · Received September 21, 2010

    Report

    Report Number
    3005075853-2010-05430
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL, WITH OPTIVIEW, TECHNOLOGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TROCAR WAS LEAKING PNEUMO. THEY COULD NOT MAINTAIN PNEUMO. THE TROCAR LEAKED WITH AND WITHOUT AN INSTRUMENT BEING INSERTED. THE TROCAR WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE PERITONITIS. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1 GM, DAILY, IP) AND REFLIN (1 GM, DAILY, IP). PD THERAPY WAS ONGOING. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4TD2N

    Patients

    Seq Age Sex Outcome Treatment
    1