BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOLOCK RESECTION DEVICE

    MDR report key: 11897785 · Received May 27, 2021

    Report

    Report Number
    1528319-2021-00017
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 27, 2021
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FDI
    PMA / PMN Number
    K140763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS HAS MADE SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE USER FACILITY TO FULLY INVESTIGATE THE REPORTED EVENT. TO DATE, THE USER FACILITY HAS NOT RESPONDED. A REVIEW OF OUR RECORDS INDICATES THAT ONE OF THE LOT NUMBERS (2010696) PROVIDED IN THE MEDWATCH REPORT DOES NOT ALIGN WITH A STERIS ENDOSCOPY LOT NUMBER. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 1912249. THE DEVICES SUBJECT OF THIS COMPLAINT WERE NOT RETURNED TO STERIS ENDOSCOPY FOR EVALUATION. WITHOUT THE DEVICE OR ADDITIONAL USER INFORMATION, THE REPORT OF DEVICE KINKING WITH ASSOCIATED GENERATOR SHORTAGE COULD NOT BE ASSESSED. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS, "THE FOLLOWING CONDITIONS MAY NOT ALLOW THE DEVICE TO FUNCTION PROPERLY OR CAUSE PATIENT INJURY: ATTEMPTING TO ADVANCE THE HANDLE TO THE OPEN POSITION WITH TOO MUCH SPEED OR FORCE, ATTEMPTING TO PASS OR OPEN THE DEVICE IN AN EXTREMELY ARTICULATED ENDOSCOPE, ATTEMPTING TO ACTUATE THE DEVICE IN AN EXTREMELY COILED POSITION AND/OR, ATTEMPTING TO ACTUATE THE DEVICE WHEN THE HANDLE IS AT AN ACUTE ANGLE IN RELATION TO THE SHEATH. IF RESISTANCE TO INSERTION IS ENCOUNTERED, REDUCE THE ANGULATION (OR LOWER THE FORCEPS ELEVATOR IF APPLICABLE) UNTIL THE INSTRUMENT PASSES SMOOTHLY. AVOID FORCEFULLY CLOSING THE SNARE (AS EVIDENT BY SHEATH COLLAPSING OR CRUSHING), WITHOUT ADEQUATE ELECTROCOAGULATION WHICH CAN CAUSE BLEEDING, INCOMPLETE CUTTING, OR SNARE INCARCERATION AROUND THE POLYP. CHECK THAT ALL ELECTRICAL CONNECTIONS ARE CORRECT. CONFIRM APPROPRIATE DISPERSIVE ELECTRODE POSITION ON THE PATIENT." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORT VIA USER FACILITY MEDWATCH REPORT MW5100226 THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PERFORMED BY A FELLOW, TWO HISTOLOCK RESECTION DEVICES KINKED CAUSING A SHORTAGE IN THE ELECTROSURGICAL GENERATOR AND RESULTING IN AN INCOMPLETE ENDOSCOPIC MUCOSAL RESECTION (EMR). THERE WAS NO REPORT OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795153 HISTOLOCK RESECTION DEVICE SNARE FDI UNITED STATES ENDOSCOPY GROUP, INC. 00711117 1912249, 2010696

    Patients

    Seq Age Sex Outcome Treatment
    1