BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLUS BLUNT GRASPER

    MDR report key: 2304672 · Received March 27, 2007

    Report

    Report Number
    1423714-2007-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2007
    Date of Event
    December 10, 2006
    Report Date
    February 16, 2007
    Manufacturer
    ENDOPLUS, INC.
    Product Code
    HET
    PMA / PMN Number
    K925079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER, (B)(6), CONFIRMED THAT THE PT IS DOING WELL WITH NO COMPLICATIONS FOLLOWING SURGERY. (B)(6) WAS UNABLE TO QUANTIFY THE NUMBER OF CASES IN WHICH THE INSTRUMENT, A 5MM LAPAROSCOPIC GRASPING FORCEP, HAD BEEN USED OR THE NUMBER OF TIMES IT HAD BEEN REPROCESSED PRIOR TO THE (B)(6) 2006 EVENT. THE INSTRUMENT WAS SHIPPED FROM ENDOPLUS TO (B)(6) MEDICAL CENTER ON (B)(6) 2005. THE COMPLAINT SAMPLE WAS DISASSEMBLED AND THE ACTUAL COMPONENTS WERE VISUALLY INSPECTED. THE EVENT WAS CAUSED BY THE SHEERING OF A RIVET WHICH CONNECTS THE ACTUATING ROD TO THE LINKS. INSPECTION OF THE BROKEN RIVET, WHICH WAS RECOVERED FROM THE SURGICAL FIELD, DID NOT REVEAL VISUAL ABNORMALITIES. INSPECTION OF THE UNBROKEN ACTUATING ROD AND LINKS, WHICH HAD BEEN CONNECTED BY THE BROKEN RIVET, DID NOT REVEAL VISUAL ABNORMALITIES. COMPLAINT HISTORY RECORDS REVEALED NO PRIOR INCIDENTS OF RIVET FAILURE BETWEEN THE ACTUATING ROD AND THE LINKS. DEVICE HISTORY RECORDS, INCLUDING MATERIAL SPECS FOR THE RIVET WERE REVIEWED AND THERE WERE NO REPORTS OF NONCONFORMANCE. SAMPLES OF ON-HAND INVENTORY WERE DIMENSIONALLY INSPECTED AND FOUND TO BE IN SPEC. AS A RESULT OF THIS INVESTIGATION, COMPLAINT HISTORY AND DHR REVIEW, ENDOPLUS BELIEVES THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ENDOPLUS BLUNT GRASPER BROKE WHILE INSIDE THE PT. SURGEON REMOVED THE INSTRUMENT, INSPECTED THE SURGICAL FIELD WITH A CAMERA AND REMOVED A SMALL BLACK SPECK OF METAL. NO OTHER FOREIGN OBJECTS WERE NOTED WITH THE CAMERA. A CHOLANGIOGRAM WAS TAKEN AND NO FOREIGN OBJECTS WERE VIEWED ON X-RAY. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND PT WAS DISCHARGED HOME IN STABLE CONDITION ON POST-OP DAY 3. BROKEN DEVICE AND METAL SPECK WERE SAVED. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLUS BLUNT GRASPER SURGICAL GRASPER HET ENDOPLUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other