BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICLIP ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 1051554 · Received May 16, 2008

    Report

    Report Number
    1037905-2008-00061
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    April 18, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K023903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PROD WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. WE WERE UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS UNAVAILABLE TO BE PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT NUMBER WAS UNABLE TO BE DETERMINED. A REVIEW OF TWELVE MO COMPLAINT HISTORY FOR HIS PROD FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CONCLUSIONS: WE ARE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE DEVICE WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: A SEPARATED HANDLE CAN OCCUR IF THE LUER LOCK IS NOT PROPERLY CONNECTED TO THE HANDLE AFTER EXPOSING THE CLIP FOR DEPLOYMENT. FAILURE TO MAKE THIS CONNECTION SECURE CAN CAUSE THE HANDLE TO SEPARATE IF THE DEVICE IS HELD AT AN ANGLE AND EXCESSIVE PRESSURE IS APPLIED TO THIS PORTION OF THE HANDLE ASSEMBLY. THE INSTRUCTIONS FOR USE FOR THIS PROD LINE ADVISE THE USER TO ADVANCE THE DEVICE THROUGH THE ACCESSORY CHANNEL IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. THE COORDINATION OF ENDOSCOPE ACCESSORY CHANNEL SIZE WITH COMPATIBLE DEVICES IS ESSENTIAL IN OBTAINING OPTIMAL RESULTS DURING USE OF THIS DEVICE. THE PROD PACKAGE LABEL INDICATES THAT THIS DEVICE IS COMPATIBLE WITH ENDOSCOPES THAT HAVE A MINIMUM ACCESSORY CHANNEL SIZE OF 3.2 MM. IF THE DEVICE IS USED WITH AN ENDOSCOPE THAT HAS AN ACCESSORY CHANNEL SMALLER THAN 3.2 MM, THIS COULD ENCOURAGE AN APPLICATION OF EXCESSIVE PRESSURE TO THE HANDLE, CONTRIBUTING TO HANDLE SEPARATION. PRIOR TO DISTRIBUTION, ALL TRICLIP ENDOSCOPIC CLIPPING DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE WORKABILITY. CORRECTIVE ACTION; NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. 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 CALCULATION, NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    A COOK ENDOSCOPIC TRI-CLIP ENDOSCOPIC CLIPPING DEVICE WAS USED. THE HANDLE SEPARATED. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADD'L INFO REGARDING PT IMPACT AND PROD USAGE. THE COMPLAINANT WAS UNABLE TO SPECIFY IF THE PT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADD'L MEDICAL PROCEDURES DUE TO THIS EVENT. HOWEVER, THE INFO PROVIDED DOES NOT REASONABLY SUGGEST THE PT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRICLIP ENDOSCOPIC CLIPPING DEVICE MCH CLIP, HEMOSTATIC MND COOK ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1