BEUDAMED
    FDA Adverse Event Other Summary report: N

    12MM, DISPOSABLE BLUNT TIP TROCAR W/SEAL

    MDR report key: 819072 · Received February 15, 2007

    Report

    Report Number
    2027111-2007-00005
    Event Type
    Other
    Date Received
    February 15, 2007
    Date of Event
    January 4, 2007
    Report Date
    February 12, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A THOUGH INVESTIGATION OF THE STABILITY CLAMP WAS CONDUCTED AFTER RECEIVING THE REPORT OF BREAKAGE. A TOTAL OF FOUR LOTS REMAINING IN FINISHED GOODS WERE INSPECTED PER ANSI Z1.4 LEVEL 1 AQL 1.0 TIGHTENED INSPECTIONS. A TOTAL OF 126 TESTS WERE CONDUCTED. EACH TEST STRESSED RIGHT OF LEFT WING (OR BOTH). IN 79% OF THE TEST ARTICLES, THE 30 LB TEST LINE BROKE PRIOR TO THE WING BREAKING. THE LOWEST RECORDED "WING" BREAKAGE WAS 18 LBS. AVERAGE BREAKAGE SEEN WAS 25 LBS. A SMALL PRECENTAGE OF UNITS BROKE WHILE TWISTING THE TEST LINE INTO THE SLOT DUE TO A TEST LINE OUTER DIAMETER THAT WAS LARGER THAN THE SMALLEST DIAMETER OF THE SLOT, NOT PRODUCT RELATED, TEST EQUIPMENT MADE PART FAIL. TEN UNITS OF THE EXISTING INVENTORY LOTS WERE TESTED UNDER REAL USE INDICATIONS, THE UNITS WERE INSERTED INTO AN ABDOMINAL WALL MODEL AND TIED DOWN UNDER NORMAL STRESS CONDITIONS FOR 2+ HOURS. NO BREAKAGE OCCURRED. ALTHOUGH THE TEST RESULTS CONCLUDED THAT A SUTURE THAT A SUTURE WOULD BREAK (BELOW 18 LBS) BEFORE WING, IT WAS NOTED THAT BY CHANGING MOLDING PARAMETERS THE UNITS BECOME EVEN MORE ROBUST. AS A PREVENTATIVE MEASURE ALL INVENTORY, WHICH UTILIZES THE STABILITY CONE, WAS REWORKED. AN ADDITIONAL INSPECTION AND PROCESS WAS ADDED TO THE MANUFACTURING PROCEDURES TO DESTRUCTIVELY TEST THE PART BEFORE RELEASING TO PRODUCT. ADDITIONALLY, IT WAS NOTED THAT ACCOUNTS THAT DID NOT NORMALLY USE THE APPLIED PRODUCT WERE IN SERVICED TO INSTRUCT USERS TO SQUEEZE THE CLAMP AND NOT UTILIZE THE WINGS TO OPEN THE DEVICE, AS IS DONE ON THE COMPETITIVE MODEL.

    Description of Event or Problem · 1

    "SUTURE TIES ON TROCAR STABILIZER BROKE DURING CASE. TIES (WINGS) BROKE DURING CASE ONCE THE SUTURES HAD ALREADY BEEN TIED. THE TIE WINGS ALSO BROKE AT THE END OF THE CASE WHEN THE SUTURE WAS BEING REMOVED FROM THE STABILIZER. INCONVINCED DURING CASE - SOME OF THE PLASTIC WING FELL INTO THE ABDOMEN AND EXTRA TIME WAS TAKEN IN REMOVING IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM, DISPOSABLE BLUNT TIP TROCAR W/SEAL DISPOSABLE TROCAR HET APPLIED MEDICAL RESOURCES CORP. C0718 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other