BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER (EXACT CODE UNK)

    MDR report key: 1790040 · Received August 3, 2010

    Report

    Report Number
    1527736-2010-00036
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    January 1, 2009
    Report Date
    August 2, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE RETURNED FOR ANALYSIS. EVALUATION SUMMARY: THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVED A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MFG RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CONVERSATION AT THE ACCOUNT, THE SURGEON MADE REF TO A CASE LAST YEAR WITH A CIRCULAR DEVICE IN WHICH THE PT RECEIVED A TRANSFUSION. NO OTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER (EXACT CODE UNK) GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other