BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE-LOCK NR ATRAUMATIC GRASPER

    MDR report key: 1922580 · Received November 19, 2010

    Report

    Report Number
    1423714-2010-00001
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ENDOPLUS
    Product Code
    HET
    PMA / PMN Number
    K925079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED, BUT WAS MADE AVAILABLE FOR INSPECTION AT THE USER FACILITY. VISUAL EXAMINATION REVEALED THAT THE DEVICE HAD BEEN SERVICED BY A THIRD PARTY, AS EVIDENCED BY A REPLACEMENT SCREW THAT WAS NOT OF AN ENDOPLUS DESIGN. THE USER FACILITY HAD ALSO INDICATED THAT THE DEVICE HAD BEEN PREVIOUSLY SERVICED IN ORDER TO REPLACE THE INSULATION SHEATHING. IT WAS ALSO NOTED THAT THE ROD OF THE DEVICE HAD A SLIGHT BEND, WHICH IS INDICATIVE OF EXCESSIVE FORCE APPLIED DURING USE OR HANDLING. THE DEVICE HISTORY RECORD AND CURRENT MANUFACTURING PROCESS WERE REVIEWED AND NO NON-CONFORMITIES WERE IDENTIFIED. A REVIEW OF COMPLAINT HISTORY INDICATES THAT THE OCCURRENCE OF JAW BREAKAGE IS RARE (TWO OCCURRENCES IN FOUR YEARS) AND HAS BEEN FOUND TO BE ASSOCIATED WITH EXCESSIVE FORCE AND/OR THIRD PARTY MODIFICATION. BASED ON THE ABOVE EVIDENCE, ALTHOUGH THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED, ENDOPLUS DOES CONCLUDE THAT THE REPORTED INCIDENT IS NOT DUE TO DEVICE DESIGN, THEREFORE, NO FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: THE PT HAD UNDERGONE A LAP HERNIA REPAIR THAT AFTERNOON. IN THE COURSE OF THE PROCEDURE, THE END OF THE GRASPER BROKE OFF AND WAS NOT ABLE TO BE RETRIEVED OVER THE COURSE OF THE NEXT TWO HOURS. DR. (B)(6) CALLED DR. (B)(6) FOR ADVICE AND A DECISION WAS MADE THAT FURTHER EFFORTS TO REMOVE THE OBJECT WOULD BE DETRIMENTAL TO THE PT. BASED ON FLUOROSCOPY, THE OBJECT IS LOCATED IN THE UPPER RIGHT QUADRANT POSTERIOR TO THE LIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIDE-LOCK NR ATRAUMATIC GRASPER SLIDE-LOCK NR ATRAUMATIC GRASPER HET ENDOPLUS 88-8233 H6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention