BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 1882609 · Received October 26, 2010

    Report

    Report Number
    1527736-2010-00083
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: REPORTEDLY, PRIOR TO THE PROCEDURE, THE PATIENT HAD BEEN USING A TENNIS BALL THROUGH THEIR ANAL ORIFICE. THIS COULD HAVE LEAD TO THE COMPLICATIONS WITH THE TISSUE BEING UNUSUALLY THICK DUE TO TRAUMA. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. 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. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THIRD HAND INFORMATION, THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THEY ATTEMPTED TO USE A CIRCULAR STAPLER FOR THE ANASTOMOSIS; HOWEVER THE STAPLES DID NOT HOLD THE TISSUE. AS A RESULT, THE ANASTOMOSIS WAS SEWN BY HAND. NO OTHER DETAILS ARE PRESENTLY KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1