BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR

    MDR report key: 6077245 · Received November 3, 2016

    Report

    Report Number
    3005075853-2016-06285
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K972578
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. CAN YOU PLEASE CLARIFY WHICH PORTION OF THE TROCAR PIECE OR PIECES WERE FOUND IN THE PATIENT. WAS THE TIP OF THE OBTURATOR FOUND IN THE PATIENT? OR WAS A PIECE OF THE TROCAR SLEEVE FOUND IN THE PATIENT? OR WAS A PIECE OF THE TROCAR HOUSING FOUND INSIDE THE PATIENT?

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N9034M, N90871. THE ANALYSIS RESULTS FOUND THAT A 23NBS DEVICE WAS RECEIVED WITH THE OUTER GASKET TORN. IN ADDITION, A PETRI DISH WAS RETURNED WITH THE PIECE OF THE OUTER GASKET. UPON VISUAL INSPECTION WITH MAGNIFICATION, THE OUTER GASKET WAS CONFIRMED TO HAVE EVIDENCE OF A MARK WHICH SUGGEST THAT A POINTY INSTRUMENT WAS INSERTED THROUGH THE TROCAR WITH EXCESSIVE FORCE. A POSSIBLE CAUSE FOR THIS DAMAGE IS THE USE OF SHARP INSTRUMENTS DURING THE PROCEDURE. USE CAUTION WHEN INTRODUCING OR REMOVING INSTRUMENTS THROUGH THE TROCAR SLEEVE IN ORDER TO PREVENT INADVERTENT DAMAGE TO THE GASKETS WHICH COULD RESULT IN LOSS OF PNEUMOPERITONEUM. SPECIAL CARE SHOULD BE USED WHEN INSERTING SHARP OR ANGLED EDGED ENDOSCOPIC INSTRUMENTS TO PREVENT TEARING THE SEAL. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, A FOREIGN MATERIAL LIKE A PARTS OF A TROCAR WAS FOUND INSIDE THE PATIENT¿S ABDOMINAL CAVITY. IT WAS RETRIEVED AND THE CASE WAS COMPLETED. NO BLEEDING OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727521 TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA N4L49R

    Patients

    Seq Age Sex Outcome Treatment
    1