BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2024304 · Received March 18, 2011

    Report

    Report Number
    3005075853-2011-01087
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    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). COMPLAINT STATED THAT THERE WAS AN OPEN, UNSEALED LINE IN THE SEAL AREA. ONE SALES UNIT WITH SIX INDIVIDUAL PACKAGES RETURNED FOR EVALUATION. THE SALES UNIT CARTON WAS IN GOOD CONDITION. FIVE OF THE PACKAGES WERE FINE WITH NO DEFECTS. ONE PACKAGE HAD AN AREA OF APPROXIMATELY 20 MM THAT WAS UNSEALED. PACKAGE WAS VISUALLY INSPECTED AND WAS FOUND TO HAVE SOME WRINKLES IN THE TYVEK CAUSED BY PACKAGE HANDLING. PACKAGE WAS PEELED OPEN FOR FURTHER EVALUATION. THERE WAS EVIDENCE OF SEAL TRANSFER FROM THE TYVEK AROUND ENTIRE CIRCUMFERENCE OF THE BLISTER. THE SEAL AREA DID NOT APPEAR TO BE NARROW OR SPOTTY OR HAVE ANY DEFECT. THE BLISTER AND THE TYVEK WERE EXAMINED BENEATH BLACK LIGHT, WHICH WILL SHOW ANY ANOMALIES IN THE SEAL. NO DEFECTS COULD BE SEEN. IT APPEARS THAT AN OBJECT MAY HAVE BEEN INSERTED INTO THE SIDE OF THE PACKAGE CAUSING SEAL TO SEPARATE. NOTHING IN THE PACKAGING PROCESS COULD HAVE CAUSED THIS TYPE OF ISSUE. IT IS UNLIKELY THAT THE OPEN SEAL WAS CAUSED WITHIN THE PACKAGING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, A PACKAGE WITH OPEN, UNSEALED LINE IN THE SEAL AREA, FOUND DURING THE LABELING PROCESS. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H43408

    Patients

    Seq Age Sex Outcome Treatment
    1