BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS WITH SPIKE

    MDR report key: 1873552 · Received September 21, 2010

    Report

    Report Number
    1037905-2010-00468
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 MONTH 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. THE SIZE OF TISSUE SAMPLE OR BIOPSY TO BE EXCISED CAN BE CONTROLLED BY HOW THE USER HANDLES THE FORCEPS. 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 LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY CAPTURA SERRATED FORCEPS WITH SPIKE. THE COMPLETED MARKETING EVAL QUESTIONAIRE INDICATED THE USER IS SATISFIED WITH EASE OF JAW OPERATION, MOVEMENT OF DEVICE THROUGH ENDOSCOPE CHANNEL, BIOPSY CAPABILITY, TISSUE ACQUISITION AND OVERALL DEVICE PERFORMANCE. HOWEVER, THE ADDITIONAL COMMENT SECTION INDICATED "THE BIOPSY STILL MORE TRAUMATIC THAN SURGICAL STEEL". UPON OUR REQUEST FOR CLARIFICATION OF THIS STATEMENT, THE USER INDICATED THE FORCEPS PULL THE MUCOSA BACK TO THE ENDOSCOPE WHERE IT THEN TEARS THE SAMPLE FROM THE MUCOSA. THE REPORTED TEARING OF THE MUCOSA DID NOT REQUIRE MEDICAL INTERVENTION. NO HARM TO THE PT OCCURRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL MEDICAL PROCEDURES DUE TO THIS OCCURRENCE. 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 FUJINON ENDOSCOPE (UNK MODEL#)