BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED LONG APPLIER

    MDR report key: 885233 · Received July 25, 2007

    Report

    Report Number
    1527736-2007-04899
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Report Date
    May 30, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/25/2007. INSTRUMENT A: DAMAGED CARTRIDGE COVER. INSTRUMENT B-G. INSTRUMENT G: BATCH # Y94A6C; EXPIRATION DATE: 05/17/2010; 06/17/2005. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (A) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (B) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (C) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (D) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (E) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (F) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS FOR THE MCM30 INSTRUMENT (G) FOUND THAT IT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH RESIDUES OF DRIED BODY FLUIDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT AS THE INSTRUMENT WAS RETURNED OUT OF ITS STERILE PACKAGE AND WITH EVIDENCE OF USE. NO FUNCTIONAL TEST WAS PERFORMED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED LESS NO OF STAPLES INSTEAD OF 20. HAD TO TAKE NEW ONE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED LONG APPLIER GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR