BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR

    MDR report key: 1840027 · Received September 21, 2010

    Report

    Report Number
    3005075853-2010-05426
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 25, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BACLOFEN DEPRIVATION SYMPTOM. THE PATIENT HAD EXPERIENCED A PSYCHOTIC SYNDROME FOR THE PREVIOUS 1.5 MONTHS IN WHICH THE PATIENT STATED THE RADIO WAS TALKING TO HER. THE PUMP RESERVOIR WAS EMPTIED AND THE ACTUAL RESIDUAL VOLUME MATCHED THE EXPECTED RESIDUAL VOLUME. THE TELEMETRY WAS REVIEWED, AND THERE WERE NO CRITICAL ALARMS OR PUMP STALL EVENTS. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED. AN AP X-RAY WAS PERFORMED AND IT VERIFIED THE CATHETER AND PUMP INTEGRITY. THERE WAS A MILD CATHETER KINK AT THE PUMP POCKET LEVEL, SO A CONTRAST TEST WAS ADMINISTERED. THIS TEST CONFIRMED, THERE WAS NO CATHETER OBSTRUCTION OR LEAKAGE. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THERE WAS EXCESSIVE LOSS OF PNEUMO FROM TROCAR SEAL. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SAME TROCAR. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1