BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 3052468 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01725
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 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 INFORMATION: WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF SO, 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? ---THE LEAK WAS COMING FROM THE CONNECTION PART OF B5LT AND A SMOKE ELIMINATION DEVICE, OLYMPUS. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? --- A FORCEPS. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AIR LEAKED FROM THE CONNECTION PART OF DEVICE B5LT AND A SMOKE ELIMINATION DEVICE (OLYMPUS). THE DOCTOR COMMENTED THAT AFTER ANOTHER B5LT HAD BEEN USED, A METALLIC SOUND HAD BEEN HEARD FROM THE CONNECTION PART OF ANOTHER B5LT AND A SMOKE ELIMINATION DEVICE (OLYMPUS). EL5ML MIGHT HAVE HIT THE MAYO TABLE BEFORE INCIDENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156760 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1