BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURA SERRATED LARGE FORCEPS - SPIKE

    MDR report key: 1719623 · Received May 7, 2010

    Report

    Report Number
    1037905-2010-00156
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 26, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOK RECEIVED A COPY OF THE MEDSUN MEDWATCH FORM (3500A) COMPLETED BY (B) (6) ON 04/26/2010. (B) (4). (B) (4). (B) (4). COOK ENDOSCOPY RECEIVED A COPY OF THIS MEDWATCH FROM FDA ON 04/26/2010. ADDITIONAL INFO: THIS REPORT WAS DETERMINED TO BE MDR REPORTABLE UPON RECEIVING THE INFO FROM THE INITIAL REPORTER. COOK ENDOSCOPY REQUESTED AUTHORIZATION TO PARTICIPATE IN FDA'S ALTERNATIVE SUMMARY REPORTING PROGRAM ON 02/09/2010. BECAUSE THE DUE DATE OF THIS MDR REPORT FELL BETWEEN 01/01/2010 - 03/31/2010, THE INFO WAS LISTED IN COOK ENDOSCOPY'S DRAFT ALTERNATIVE SUMMARY REPORT TO BE SUBMITTED TO FDA ON 04/30/2010. ON 04/01/2010, FDA WAS CONTACTED BY COOK ENDOSCOPY TO INQUIRE AS TO THE STATUS OF AUTHORIZATION TO PARTICIPATE IN THE ASR PROGRAM. FDA CONTACTED COOK ENDOSCOPY ON 04/05/2010 AND INFORMED US THAT OUR REQUEST TO PARTICIPATE HAD BEEN DECLINED BECAUSE THE RATE OF THESE REPORTS IS BELOW THE MINIMUM FOR PARTICIPANT CONSIDERATION. THEREFORE, THIS REPORT IS BEING SUBMITTED ON THE INDIVIDUAL MEDWATCH FORM - 3500A. EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER COULD NOT BE DETERMINED. 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 EVALUATION. 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. 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 LARGE FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. CORRECTIVE ACTION. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN INFORMED OF THIS TYPE OF OCCURRENCE AND THIS WAS BROUGHT TO THE ATTENTION OF THE QUALITY REVIEW BOARD (QRB). NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THE REPORTED OCCURRENCE COULD NOT BE VERIFIED AND THE REPORT OF PERFORATION REPRESENTS A POTENTIAL COMPLICATION WITH THIS PROCEDURE. 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 PHYSICIAN USED A COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEPS WITH SPIKE TO TAKE A BIOPSY IN THE COLON. AFTER THE COLONOSCOPY, HEMORRHAGE TO 8.5 HEMOGLOBIN (HGB) OCCURRED. THE PHYSICIAN INDICATED THE FORCEPS MAY HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION. ANOTHER COLONOSCOPY WAS REQUIRED AND THE SITE WAS CLIPPED. TRANSFUSION OF RED CELLS WAS PERFORMED AS WELL. ADDITIONAL INFO REGARDING PT OUTCOME AND PRODUCT USAGE WAS REQUESTED BUT THE INFO WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| O ENDOSCOPE (UNKNOWN TYPE)