BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC TROCAR

    MDR report key: 1872971 · Received October 18, 2010

    Report

    Report Number
    3005075853-2010-05912
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 2010
    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). DAMAGED CANNULA. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE, "THE NURSE CONFIRMED THAT THE DEVICE WAS NORMAL WITHOUT DAMAGE BEFORE USE. THE DOCTOR COMMENTED THAT HE MIGHT HAVE ADDED EXCESSIVE FORCE TO THE DEVICE WHEN THE SCOPE AND THE ENDOCUTTER (COVIDIEN) WERE INSERTED." THE VIDEO OF THE PROCEDURE WAS RETURNED AND REVIEWED BY AN EES DESIGN ENGINEER. THE FOLLOWING SUMMARY WAS PROVIDED, "THE VIDEO PROVIDED WITH THIS COMPLAINT WAS REVIEWED. THE DEVICE WAS OBSERVED DURING USE. IT COULD NOT BE DETERMINED FROM THE VIDEO WHAT CAUSED THE FRACTURE ALONG THE CANNULA NOR WHEN THE FRACTURE OCCURRED DURING THE PROCEDURE. MISUSE WAS NOT OBSERVED." THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE SLEEVE BROKEN AND CRACKED. THE BROKEN PIECE WAS RETURNED FOR EVALUATION. 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. 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 THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE DEVICE WAS USED AS A CAMERA PORT. ENDO-CUTTER WAS ALSO INSERTED THROUGH THE DEVICE. IT WAS FOUND THAT THE ACRAL PART OF THE SLEEVE WAS CRACKED WHEN THE SURGICAL INSTRUMENTS WERE CLEANED AFTER THE OPERATION. SINCE THE CRACKED PIECE WAS MISSING, THE PATIENT GOT A CT SCAN AT 5 MM INTERVALS. HOWEVER, THE CRACKED PIECE COULD NOT BE FOUND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1