BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH* TROCAR

    MDR report key: 2022305 · Received March 17, 2011

    Report

    Report Number
    3005075853-2011-01060
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEA
    PMA / PMN Number
    K920110
    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). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE SLEEVE BROKEN AND CRACKED. THE BROKEN PIECE WAS MISSING. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE DEVICE OCCURRED. 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 LOBECTOMY PROCEDURE, THE SLEEVE WAS BROKEN DURING USE. THE DEVICE WAS USED AS A CAMERA PORT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED THAT HE DID NOT ADD EXCESSIVE POWER SO MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* TROCAR GEA ETHICON ENDO-SURGERY, LLC. NA G4U599

    Patients

    Seq Age Sex Outcome Treatment
    1