BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS WITH SPIKE

    MDR report key: 1881393 · Received October 7, 2010

    Report

    Report Number
    1037905-2010-00489
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS 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. HEMORRHAGE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY. IF EXCESSIVE PRESSURE WAS APPLIED DURING ADVANCEMENT INTO THE TISSUE OR DURING HANDLE MANIPULATION, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ADVANCE THE FORCEPS INTO THE TISSUE AT THE DESIRED BIOPSY SITE. THEN THE USER IS INSTRUCTED TO CLOSE THE FORCEPS AROUND THE TISSUE WHILE USING SLIGHT PRESSURE ON THE HANDLE. THE USER IS INSTRUCTED TO MAINTAIN GENTLE HANDLE PRESSURE TO KEEP THE CUPS CLOSED AND GENTLY WITHDRAW THE FORCEPS FROM THE SITE. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT 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 REVIEW, NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE INFO RELATED TO THIS OCCURRENCE WAS PROVIDED TO COOK VIA COMPLETION OF A MARKETING EVAL QUESTIONNAIRE BY THE INITIAL RPTR. ACCORDING TO THE QUESTIONNAIRE, THE INITIAL RPTR CURRENTLY USES/PREFERS OLYMPUS BRAND OF FORCEPS. DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY CAPTURA SERRATED FORCEPS WITH SPIKE. THE USER INDICATED THEY ARE SATISFIED WITH EASE OF JAW OPERATION AND TISSUE ACQUISITION. HOWEVER, THE ADD'L COMMENTS SECTION OF THE QUESTIONNAIRE INDICATED THE FORCEPS TOOK TWO ACCEPTABLE BIOPSIES BUT REPORTEDLY OOZED MORE BLOOD THAN THE CURRENT FORCEPS USED (I.E. OLYMPUS BRAND). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURA SERRATED FORCEPS WITH SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL COOK ENDOSCOPY W2897436

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF H180 ENDOSCOPE