BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 4222754 · Received November 4, 2014

    Report

    Report Number
    3005075853-2014-07542
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 6, 2014
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THERE WERE NO POST ¿OPERATIVE COMPLICATIONS WITH THE PATIENT AND EVERYTHING IS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT WHAT POINT OF THE PROCEDURE DID THE SURGEON OBSERVE THE TIP OF THE TROCAR BROKE? WHAT WAS THE SURGEON DOING AT THE TIME OF THE BREAK? DOES THE SURGEON BELIEVE THE TROCAR WAS LEFT IN THE PATIENT? IS THERE A POSSIBILITY THE PIECE OF THE TROCAR BROKE OUTSIDE THE PATIENT? IS THERE A POSSIBILITY THE PIECE OF THE TROCAR WAS NOT LEFT IN THE PATIENT? HAS THE PATIENT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS? THE ANALYSIS RESULTS FOUND THAT THE B5LT DEVICE WAS RECEIVED WITHOUT THE SLEEVE ASSEMBLY, ONLY THE OBTURATOR WAS RETURNED. DURING THE INSPECTION WITH MAGNIFICATION, THE CLEAR LENS WAS FOUND TO BE MELTED AND A PORTION OF THE LENS WAS MISSING. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE INTERACTION WITH AN ENERGIZED DEVICE USED DURING THE PROCEDURE. CAUTION SHOULD BE TAKEN TO AVOID CONTACT BETWEEN AN ENERGIZED DEVICE AND THE TROCAR DURING THE SURGICAL PROCEDURE. 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 A LAPAROSCOPIC APPENDECTOMY PROCEDURE, BLUNT TIP OF THE TROCAR BROKE OFF DURING PROCEDURE. ONCE THE SURGEON BECAME AWARE OF SITUATION, THEY PLACED IRRIGATION ON THE PATIENT AND USED SUCTION TO REMOVE THE IRRIGATION; HOWEVER COULD NOT FIND MISSING PIECE. CONTINUED WITH PROCEDURE, PATIENT IS FINE AND HAS RETURNED HOME. UNKNOWN DELAY TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706566 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1