BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CORD 12/BX STE RILE

    MDR report key: 15480543 · Received September 24, 2022

    Report

    Report Number
    3005975494-2022-00043
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 11, 2022
    Report Date
    July 3, 2023
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    04042761001656
    PMA / PMN Number
    K844565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE ISSUE IS UNKNOWN AT THIS TIME. FOLLOW UP IS IN PROGRESS. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. DUE TO NO DEVICE RETURN, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AND A POSSIBLE CAUSE COULD NOT BE DETERMINED. THE EXACT MODEL OF THE COMPLAINT WAS UNKNOWN. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED AGAINST THE SELECTED MODEL 5142708 (MODEL PROVIDED ON THE INITIAL REPORT). OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON DEVICE RETURN EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. IN ADDITION, THIS REPORT IS BEING SUPPLEMENTED TO INFORM CORRECTION TO D4 OF THE INITIAL MEDWATCH. THE DEVICE MODEL IS BEING CORRECTED FROM MODEL 5142708 TO MODEL A0393, LOT 246735. PLEASE SEE SECTION D4 FOR THE UPDATES. ADDITIONALLY, THE MANUFACTURING REGISTRATION NUMBER IS BEING CORRECTED FROM (B)(4) TO (B)(4). THE CORRECT MANUFACTURING REGISTRATION NUMBER IS (B)(4). THE SUBJECT DEVICE WAS EVALUATED. DEVICE EVALUATION NOTED THE CABLE IS BROKEN/DETACHED FROM THE INSTRUMENT CONNECTOR PLUG. THERE WAS EVIDENCE OF CHARRED MARKS AND ON THE BROKEN AREA OF THE CABLE. DISCOLORATION ON THE CABLE NEAR THE BROKEN SITE OF THE CABLE. THERE WAS CRACKS AND DISCOLORATION NOTED ON THE DETACHED/BROKEN APART PLUG. THE LIGHT GUIDE CONNECTOR IS STILL INTACT TO THE CABLE BASED ON THE PHOTO PROVIDED. THE ERROR DESCRIPTION PROVIDED IS PLAUSIBLE. THE ERROR DESCRIBED IS A KNOWN ERROR PATTERN AND CAN BE CONFIRMED. THE AGE-RELATED WEAR IN CONNECTION WITH REPEATED EXTREME BENDING OR TENSILE LOADS MOST LIKELY LED TO THE BREAKAGE OF SINGLE OR ALL THE WIRES IN THE CABLE. IT SHOULD BE NOTED THAT THIS CAN CAUSE A VOLTAGE SPIKE AT THE DAMAGED AREA WHEN THE GENERATOR IS ACTIVATED, RESULTING IN A SPARK AND COMPLETE DISCONNECTION OF THE PLUG. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR DEVICE A0393 WITH LOT NUMBER 246735. THERE IS NO NON-CONFORMITY ASSOCIATED WITH THIS DEVICE WITH RESPECT TO THE DESCRIBED ISSUE. THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. IN ORDER TO AVOID SUCH INCIDENTS, THE INSTRUCTIONS FOUND IN THE INSTRUCTIONS FOR USE (IFU ) SHOULD BE FOLLOWED. THIS WOULD BE, FIRSTLY, THAT THE SERVICE LIFE OF THE CABLE IS LIMITED TO 12 MONTHS. AFTER THIS TIME, THE CABLE SHOULD NO LONGER BE USED. ADDITIONALLY, THE CABLE MUST BE CHECKED FOR DAMAGE BEFORE EACH USE AND AFTER REPROCESSING. BY GENTLY PULLING ON THE PLUG (MAX. 20N), IT CAN BE DETERMINED WHETHER THE COPPER STRAND OF THE CABLE IS ALREADY DAMAGED. IF THE CABLE DOES NOT GIVE WAY BUT REMAINS RIGID, THE CABLE IS MOST LIKELY INTACT. IN ORDER NOT TO SHORTEN THE SERVICE LIFE OF THE CABLE ANY FURTHER, THE CABLE SHOULD NOT BE WOUND UP WITH A LOOP DIAMETER OF LESS THAN 10CM AND WHEN PULLING OUT THE CABLE, THE PLUG SHOULD BE PULLED AND NOT THE CABLE. IT IS EVIDENT FROM THE LOT NUMBER THAT THE CABLE WAS MANUFACTURED IN NOVEMBER OF 2002. THIS MEANS THAT THE CABLE IS OVER 20 YEARS OLD. IT CAN THEREFORE BE ASSUMED THAT THE CABLE WAS USED FOR LONGER THAN THE SPECIFIED 12 MONTHS. THE CAUSE OF THE REPORTED ISSUE IS MOST LIKELY DUE TO WEAR AND TEAR IN CONNECTION WITH IMPROPER HANDLING. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED A MEDWATCH REPORT WITH AN EVENT PROBLEM/ AS REPORTED BY THE REPORTER, STATED " REUSABLE MONOPOLAR CORD FOR CYTO INSTRUMENTATION SPARKED AND BURNED COMPLETELY THROUGH WHEN BEING USED DURING PROCEDURE. NO PATIENT OR STAFF INJURY OCCURRED. CORD WAS IMMEDIATELY THROWN OFF THE FIELD, A NEW ESU (ELECTROSURGICAL UNIT) AND MONOPOLAR CORD WAS ACQUIRED, AND USED TO FINISH THE CASE WITHOUT INCIDENT. THE ESU IN USE AT THE TIME OF THE ISSUE WAS SEQUESTERED". THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666004 ENDOSCOPIC CORD 12/BX STE RILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC A0393 246735 04042761001656

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown