BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR SLEEVE 10/110MM SMOOTH WITH TAP

    MDR report key: 4507189 · Received February 3, 2015

    Report

    Report Number
    2916714-2015-00061
    Event Type
    Malfunction
    Date Received
    February 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K101937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    U.S. AGENT NOTIFIED ON: (B)(4) 2015. MANUFACTURING SITE EVALUATION: INSTRUMENTS HAVE BEEN CHECKED MICROSCOPICALLY. NO MICRO CRACKS OR OTHER DAMAGES COULD BE FOUND. THE MONOPOLAR INSTRUMENTS WERE CHECKED IN THE MANUFACTURING DEPARTMENT REGARDING ELECTRICAL DISCHARGE. ALL INSTRUMENTS WERE FOUND TO BE WITHOUT FAILURES. NO DEVIATIONS FROM OEM SPECIFICATIONS COULD BE VERIFIED. THERE ARE NO INDICATIONS FOR MATERIAL OR PRODUCT DEVIATIONS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CUSTOMER STATES INSTRUMENTS ARE NOT IN GOOD CONDITION, AND THE SHEATHS MAY HAVE MICRO CRACKS. THERE WAS A LESION, BY BURN, IN THE AREA OF SURGERY. INSTRUMENTS FROM SET INCLUDE: PO004R METZENBAUM SCISSORS 5MM 310MM (PO603R; PM973R; PO958R); PO102R MARYLAND DISSECTOR 5MM 310MM (PO608R; PM973R; PO958R); PO128R CLINCHING GRASPER FENEST 5MM 310MM (PO770R; PM973R; PO959R); PO191R UNIVERSAL GRASPER 5MM 3 (PO736R; PM973R; PO959R); GK373R INNER TUBE W/HANDLE FOR GK372R; GK384R CERAMIC ELECTRODE TIP L-HK F/GK372R; EK024R TROCAR SLEEVE 10/110MM SMOOTH WITH TAP; EK014R TROCAR SLEEVE 5/110MM SMOOTH WITH TAP; EK064R TROCAR PIN BLUNT (HASSON) 10/110MM; EK046R TROCAR PIN CONICAL SHARP 5/110MM. MEDWATCH FILED ON MOST LIKELY COMPONENT TO HAVE BEEN CAUSED THE BURN. ALL OTHER COMPONENTS WERE USED WITHIN THE CASE AND ARE BEING EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78055 TROCAR SLEEVE 10/110MM SMOOTH WITH TAP LAPAROSCOPIC TROCAR GCJ AESCULAP AG & CO. KG EK024R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other