BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS W/O SPIKE

    MDR report key: 3904667 · Received May 23, 2014

    Report

    Report Number
    1037905-2014-00212
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION 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. 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. INSTRUCTIONS FOR USE WARNING: THESE SINGLE-USE FORCEPS SHOULD ONLY BE USED TO BIOPSY TISSUE WHERE POSSIBLE BLEEDING OR HEMORRHAGE WILL NOT PRESENT A DANGER FOR PATIENTS. ADEQUATE PLANS FOR MANAGEMENT OF POTENTIAL BLEEDING OR HEMORRHAGE AND APPROPRIATE AIRWAY MANAGEMENT SHOULD BE IN PLACE. INSTRUCTIONS FOR USE LISTS POTENTIAL COMPLICATIONS AS: THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE BUT ARE NOT LIMITED TO: PERFORATION, BLEEDING OR HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST CARDIAC ARRHYTHMIA OR ARREST. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A COOK CAPTURA SERRATED FORCEPS WITHOUT SPIKE WAS USED. GENERAL FEEDBACK FROM PHYSICIANS STATED: THE PHYSICIANS FEEL THE FORCEPS AREN'T AS SHARP. THE FORCEPS RIP INSTEAD OF BITE. AN EXACT QUANTITY WAS REQUESTED BUT WAS UNABLE TO BE SPECIFIED BY THE INITIAL REPORTER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309165 CAPTURA SERRATED FORCEPS W/O SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)