BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7FR COAX HEMOSTATIC PROBE

    MDR report key: 8804125 · Received July 18, 2019

    Report

    Report Number
    2951238-2019-01015
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 20, 2019
    Report Date
    October 25, 2019
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    KNS
    PMA / PMN Number
    K123319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE DEVICE EVALUATION RESULTS AND ADDITIONAL INFORMATION. PLEASE THE UPDATES IN SECTIONS: D10, G4, G7, H2, H3, H6 AND H10. THE CUSTOMER RETURNED A CD-B620LA 7 FR HEMOSTATIC PROBE .THE DEVICE WAS RETURNED IN THE ORIGINAL TYVEK POUCH. THE PACKAGE LOT NUMBER, KR852062 AND DEVICE LOT NUMBER, KR848640. UPON INSPECTION OF THE RETURNED DEVICE IT WAS NOTED THAT THE DISTAL CERAMIC TIP WAS COMPLETELY SEPARATED. THE CERAMIC TIP WAS NOT RETURNED WITH THE DEVICE. NO ADDITIONAL ANOMALIES WERE NOTED. THE PLASTIC JACKET, CORD AND PLUG WERE ALL IN GOOD CONDITION WITH NO APPARENT DAMAGE. THE PLASTIC JACKET WAS REMOVED. PRESENCE OF ADHESIVE WAS NOTED ON THE DISTAL END HOWEVER IT APPEARS THE ADHESIVE HAD NOT BONDED WELL TO THE DISTAL CERAMIC TIP. ADDITIONALLY THE WIRES REVEALED AFTER REMOVING THE PLASTIC JACKET WERE STRIPPED AND INTACT SUGGESTING THEY WERE NOT PROPERLY BONDED TO THE CERAMIC TIP. THE DEVICE-LEVEL DHR FOR THIS PRODUCT HAS BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. A TOTAL OF 40 UNITS WERE PRODUCED UNDER THIS LOT NUMBER WITH NO RECORDED PROCESS DEVIATIONS RELATING TO THE REPORTED FAILURE. THE MANUFACTURING PROCEDURE STATES, "FIRMLY TUG ON ALL CERAMIC TIPS TO CONFIRM STRONG BODS. REJECT ANY DEVICE WHERE THE TIP IS REMOVED FROM THE BODY STOCK AFTER TUGGING." AS THE DEVICE FAILED UPON INSERTION AND VISUAL INSPECTION YIELDS NO EVIDENCE TO SUGGEST MISUSE OF THE DEVICE, THE CUSTOMERS FAILURE CAN LIKELY BE ATTRIBUTED TO OPERATOR ERROR DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER AND IS PENDING EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THE CD-B620LA INSTRUCTION MANUAL PROVIDES USERS SEVERAL WARNINGS TO MITIGATE DAMAGE TO THE PROBE. " INSPECT THE PROBE FOR TUBING KINKS AND ANY OTHER DEFECTS. DO NOT USE IF DAMAGED. INSERT THE INSTRUMENT SLOWLY; ABRUPT INSERTION MAY CAUSE DAMAGE TO THE ENDOSCOPE AND/OR INSTRUMENT. CAUTION INDICATES A POTENTIALLY HAZARDOUS SITUATION, WHICH, IF NOT AVOIDED, MAY RESULT IN MINOR OR MODERATE INJURY. IT MAY ALSO BE USED TO ALERT AGAINST UNSAFE PRACTICES OR POTENTIAL EQUIPMENT DAMAGE. "

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING AN UPPER ENDOSCOPY PROCEDURE, THE PROBE TIP DETACHED, WHILE ATTEMPTING TO INSERT THE INSTRUMENT INTO THE SCOPE CHANNEL. THE DETACHED TIP DID NOT AFFECT THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598413 7FR COAX HEMOSTATIC PROBE HEMOSTATIC PROBE KNS GYRUS ACMI, INC CD-B620LA KR852062

    Patients

    Seq Age Sex Outcome Treatment
    1