BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS WITH SPIKE

    MDR report key: 1659364 · Received April 12, 2010

    Report

    Report Number
    1037905-2010-00077
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Report Date
    January 27, 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 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. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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 OBSERVATIONS. 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 DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS TYPE OF OCCURRENCE IN AN EFFORT TO HEIGHTEN AWARENESS. THIS WAS BROUGHT TO THE ATTENTION OF THE QUALITY REVIEW BOARD (QRB). 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 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

    DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED COOK ENDOSCOPY CAPTURA SERRATED BIOPSY FORCEPS WITH SPIKE. THE FORCEPS REPORTEDLY CREATED TEARING OF THE TISSUE INSTEAD OF CLEANLY EXCISING THE TISSUE. THE REPORTED TEARING OF THE TISSUE DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION. 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.

    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 W2757017

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS 180 SERIES ENDOSCOPE