BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPTS W/O SPIKE

    MDR report key: 2102273 · Received May 23, 2011

    Report

    Report Number
    1037905-2011-00308
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Report Date
    April 22, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FCL
    PMA / PMN Number
    K923847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. UNUSED PRODUCT FROM VARIOUS LOT NUMBERS WERE PROVIDED BY THE REPORTER FOR EVAL. THE UNUSED PRODUCT HAS BEEN RETURNED TO THE APPROVED FORCEPS SUPPLIER FOR EVAL. WE HAVE NOT YET RECEIVED THE EVAL RESULTS FROM THE APPROVED SUPPLIER. A F/U MDR WILL BE SUBMITTED ON OR BEFORE (B)(4) 2011. THE POSSIBLE LOT NUMBERS OF THE PRODUCT SAID TO BE INVOLVED WERE USED TO REVIEW THE DEVICE HISTORY RECORDS. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS UNABLE TO BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REPORT, THE LIKELIHOOD OF THE TYPE OF REPORT IS RARE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED FORCEPS W/O SPIKE ARE SUBJECTED TO A VISUAL INSPECTION FOR PRODUCT INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOT NUMBERS CONFIRMED THAT THE LOTS SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OBSERVED THAT THE FORCEPS TAKE TOO LARGE OF A TISSUE SPECIMEN. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURA SERRATED FORCEPTS W/O SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE: (UNK MODEL)