BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 3221229 · Received July 11, 2013

    Report

    Report Number
    3005075853-2013-03521
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 4, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DID THE NOISE PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ---FROM THE VALVE. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? ---NO. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. THE ANALYSIS RESULTS FOUND THAT DEVICES (A, B AND C) WERE RETURNED IN GOOD CONDITION AND INSIDE THEIR ORIGINAL PACKAGES. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, EACH DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICES, THEY WERE FUNCTIONALLY LEAK TESTED AND PASSED. EACH DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICES (D AND E) WERE RETURNED IN GOOD CONDITION AND INSIDE THEIR ORIGINAL PACKAGES. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, EACH DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICES, THEY WERE FUNCTIONALLY LEAK TESTED AND PASSED. EACH DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICES (D AND E) ADDITIONAL INFORMATION: BATCH # K90R0X, EXPIRATION DATE: 02/2018, MANUFACTURING DATE: 03/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION OF RECTUM PROCEDURE, AIR LEAKED WITH A BOO NOISE IN 3 DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE THREE DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320654 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4CN89

    Patients

    Seq Age Sex Outcome Treatment
    1