BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*THORACIC TROCAR SLEEV

    MDR report key: 1891786 · Received November 5, 2010

    Report

    Report Number
    3005075853-2010-06326
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 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 SLEEVE. ADDITIONAL INFORMATION: THE NURSE WAS CONFIRMED THAT THE DEVICE WAS NORMAL WITHOUT DAMAGE BEFORE USE. ALTHOUGH X-RAY WAS TAKEN AFTER THE OPERATION, THE BROKEN PIECE WAS NOT FOUND. THE DOCTOR COMMENTED THAT HE MIGHT HAVE ADDED EXCESSIVE FORCE TO THE DEVICE AND HIT THE TIP OF THE DEVICE WHEN THE SCOPE AND THE ENDO CUTTER ((B)(4), (B)(4), (B)(4)) WERE INSERTED. AGE, SEX, WEIGHT, PRIMARY DISEASE: WE HAVE NO DETAILED INFORMATION. STATUS: THE PATIENT WAS GETTING WELL. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE SLEEVE BROKEN AND CRACKED. THE BROKEN PIECE WAS NOT 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 VALID 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, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS FOUND THAT THE ACRAL PART OF THE SLEEVE WAS CRACKED. THE DOCTOR TRIED TO FIND THE MISSING PIECE AS MUCH AS POSSIBLE, BUT NO PIECE WAS FOUND INSIDE THE OPERATION FIELD. SO THE OPERATION FIELD WAS CLOSED. AS THE SUCTIONING WAS PERFORMED BEFORE CLOSING CHEST, THE BROKEN PIECE MIGHT HAVE BEEN SUCTIONED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1