BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONT LOADING SUPER-LOOP ELEC (BOX OF 5)

    MDR report key: 8826867 · Received July 25, 2019

    Report

    Report Number
    2951238-2019-01022
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 25, 2019
    Report Date
    September 17, 2019
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K031085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOOP WAS RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION (OEM). THE OEM REPORTED THAT THE DEVICE WAS RECEIVED WITH THE LOOP BADLY DEFORMED WHICH WOULD DRASTICALLY IMPACT THE ELECTRODES ABILITY TO RESECT TISSUE. THE DAMAGE IS MOST PROBABLY A RESULT OF HANDLING DAMAGE OR INCORRECT ASSEMBLY TECHNIQUE. THE DEVICE SUCCESSFULLY PASSED THE ELECTRICAL AND FUNCTIONAL TESTS. THE COMPLAINT FAILURE MODE HAS BEEN REVIEWED AGAINST THE SYSTEMS RISK ASSESSMENT DOCUMENT, 844027 WHICH WAS RECORDED IN SECTION 3.5.2 ACCIDENTAL MECHANICAL DAMAGE - ELECTRODE TIP GEOMETRY COMPROMISED DUE TO TRANSPORTATION/STORAGE/MISUSE/USER ERROR, RESULTING IN REDUCED TISSUE EFFECT AND INCREASED DRAG.

    Additional Manufacturer Narrative · 1

    THE LOOP WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED DEVICE AND FOUND CHARRED STAINS WITH LOOP BENT DOWN CONSISTENT WITH USE. THE DISTAL SECTION WAS ALSO BENT INWARDS. HOWEVER, THERE IS NO MISSING FRAGMENT, AND THE HF CABLE APPEARED TO BE INTACT. TO PERFORM FUNCTIONAL INSPECTION, THE ELECTRODE WAS CHECKED WITH OUR TEST WORKING ELEMENT EIWE AND A PK/SP GENERATOR. THE GENERATOR DISPLAYED A DEFAULT SETTING SP2/160 AND DES/80. IT WAS OBSERVED THAT THE ELECTRODE LOOP DID GENERATE THE OUTPUT AND HEAT UP IN A SALINE SOLUTION, WHEN THE FOOTSWITCH WAS BEING ACTIVATED. THE CUTTING LOOP WAS ABLE TO RESECT PIECES OF TISSUE SAMPLES WITHOUT ISSUE. PRODUCTION RECORDS WERE REVIEWED AND THERE ARE NO ANOMALIES OR DISCREPANCIES APPLICABLE TO THIS LOT NUMBER. BASED ON THE EVALUATION FINDINGS, THE REPORTED COMPLAINT WAS NOT DUPLICATED. THE DAMAGE ON THE ELECTRODE CUTTING LOOP COULD BE THE RESULT OF EXCESSIVE FORCE AND MISHANDLING. THE 784415 INSTRUCTION MANUAL STATES ¿INSPECT DEVICE AND PACKAGING PRIOR TO USE FOR DAMAGE OR DEFECTS THAT MIGHT CAUSE A SAFETY HAZARD.¿

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING A THERAPEUTIC BLADDER TUMOR REMOVAL PROCEDURE, THE SURGEON REPORTED THE LOOP VAPORIZED TISSUE RATHER THAN RESECTED. THE ISSUE STARTED RIGHT AT THE START OF USE. WHEN A NEW DISPOSABLE WAS OPENED, THE TIPS LOOKED COMPLETELY DIFFERENT. A SECOND DISPOSABLE WAS USED AND WORKED AS EXPECTED. NO UNEXPECTED BLEEDING REPORTED. NO PIECES BROKE OFF THE DEVICE. NO LONGER STAY OR ADDITIONAL PROCEDURES NEEDED FOR THE PATIENT. THE PROCEDURE WAS NOT PROLONGED. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622344 FRONT LOADING SUPER-LOOP ELEC (BOX OF 5) ELECTRODE, SUPERLOOP GEI GYRUS ACMI, INC 784415 U1903069

    Patients

    Seq Age Sex Outcome Treatment
    1