BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10FR FIXEDPIN HEMOSTATIC PROBE

    MDR report key: 16777947 · Received April 20, 2023

    Report

    Report Number
    3005975494-2023-00079
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 23, 2023
    Report Date
    June 21, 2024
    Manufacturer
    GYRUS ACMI L.P.
    Product Code
    KNS
    UDI-DI
    00821925039476
    PMA / PMN Number
    K123319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESPONSE TO FOLLOW UP. COMMUNICATION WITH THE CUSTOMER VIA COMPANY REPRESENTATIVE, THE FOLLOWING INFORMATION WERE PROVIDED : THE INTENDED PROCEDURE WAS A THERAPEUTIC UPPER GI ENDOSCOPY, COMPLETED WITH THE SAME DEVICE. THE DURATION THAT THE PROCEDURE WAS PROLONGED, AND THE PATIENT¿S ANESTHESIA OR SEDATION WAS EXTENDED WAS NOTED "UNKNOWN", HOWEVER, IT WAS REPORTED THAT THERE WAS NO MEDICAL INTERVENTION PERFORMED AS A RESULT OF THE EVENT. NO FRAGMENTS FALL INSIDE THE PATIENT DURING THE PROCEDURE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH INCORRECTLY REPORTED THE SITE REGISTRATION NUMBER. THE SITE REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS INSPECTED, AND THE COMPLAINT WAS CONFIRMED. THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGING. THE MODEL WAS CONFIRMED TO BE CD-B612LA AND LOT WAS KR200146. UPON INSPECTION, IT WAS OBSERVED THAT THE PROBE SHEATH ABOVE THE HEMOSTASIS TIP WAS BROKEN BUT NOT COMPLETELY DETACHED, AND THE INTERNAL WIRES REMAINED INTACT. THE PRESENCE OF BLOOD RESIDUE ON THE SHEATH, ON THE PROBE TIP, AND INSIDE THE LUER, INDICATED PRIOR USAGE. NO OTHER DAMAGES WERE OBSERVED BESIDES THE BROKEN TIP. TO TEST FUNCTIONALITY, THE DEVICE WAS CONNECTED TO A BIPOLAR GENERATOR, AND THE TIP WAS SUBMERGED IN A SMALL AMOUNT OF SALINE. THE APPLICATION OF ENERGY RESULTED IN BUBBLING OF THE SALINE, INDICATING PROPER ENERGY TRANSMISSION. DUE TO THE BROKEN TIP, TESTING OF IRRIGATION CAPABILITY WAS NOT POSSIBLE. IN SUMMARY, THE DEVICE FUNCTIONED AS INTENDED, HOWEVER, THE PROBE SHEATH ABOVE THE HEMOSTASIS TIP WAS BROKEN. REVIEW OF DEVICE HISTORY RECORD (DHR) RECORDS PROVIDED NO INDICATION THAT MANUFACTURING PROCEDURES CONTRIBUTED TO THE REPORTED EVENT. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. BASED ON INSPECTION FINDINGS, THE OBSERVED SHEATH FRACTURE MAY HAVE RESULTED FROM THE PROBE BEING BUCKLED AND BOUND INSIDE THE SCOPE'S CHANNEL WITH EXCESSIVE FORCE OR THE DISTAL PROBE TIP BEING SUBJECTED TO BLUNT FORCE AGAINST A HARD OBJECT. HOWEVER, THE EXACT CAUSE COULD NOT BE DEFINITIVELY DETERMINED DURING THE INVESTIGATION. PAGE 6 OF THE DEVICE IFU (INSTRUCTIONS FOR USE_P9100505-001_AH) ADDRESSES THIS: "DO NOT USE THE DEVICE IF RESISTANCE TO INSERTION IS ENCOUNTERED. REDUCE THE ANGLE OR LOWER THE FORCEPS ELEVATOR OF THE ENDOSCOPE UNTIL THE DEVICE PASSES SMOOTHLY; DO NOT ADVANCE OR EXTEND THE DEVICE ABRUPTLY; INSERT THE DEVICE SLOWLY. ABRUPT INSERTION MAY CAUSE DAMAGE TO THE ENDOSCOPE OR THE DEVICE." IN ADDITION, PAGE 3 OF THE IFU STATES ¿KEEP THE DEVICE TIP IN SIGHT DURING USE. INADVERTENT ACTIVATION OR MOVEMENT OF THE DEVICE OUTSIDE THE FIELD OF VISION MAY RESULT IN PATIENT INJURY" OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: D3, G1, H11 THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION IS STILL PENDING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE WAS USED AT THE OPERATING ROOM (OPERATING THEATRE) AND DURING THE PROCEDURE (AN UNSPECIFIED PROCEDURE), THE SHEATH OF BICOAG PROBE WAS FRACTURED BEFORE THE USER APPLY THE HEAT ENERGY. THERE WAS NO ADVERSE EVENT REPORTED. NO HARM OR INJURY TO PATIENT WAS REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746372 10FR FIXEDPIN HEMOSTATIC PROBE HEMOSTATIC PROBE KNS GYRUS ACMI L.P. CD-B612LA KR200146 00821925039476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown