BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE APC FILTER INTEGRATED SIDE FIRE PROBE

    MDR report key: 15013151 · Received July 14, 2022

    Report

    Report Number
    9610614-2022-00022
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT ISSUE WAS REPORTED INVOLVING AN APC PROBE DURING AN ENDOSCOPIC INTERVENTION. THE APC PROBE WAS USED WITH AN ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU) SYSTEM. NO SETTINGS WERE PROVIDED. WHEN THE PROBE WAS ACTIVATED, A BREACH (HOLE) WAS NOTICED IN THE TUBING AT THE BLACK MARK THAT WAS CLOSEST TO THE TIP CAUSING THE PROBE TO HAVING TWO COAGULATION BEAMS (ONE AT THE TIP AS INTENDED AND THE OTHER WHERE THE BREACHED OCCURRED). NO PATIENT INJURY OCCURRED. NARRATIVE: A PHOTOGRAPH OF THE APC PROBE WAS PROVIDED WHICH CONFIRMED THE REPORTED ISSUE. THERE WAS A SMALL HOLE WITH A THERMAL MATERIAL CHANGE IN THE TUBING THAT INDICATED THE PRESENCE OF A COAGULATION BEAM AS REPORTED (NOTE: THE PROBE WAS NOT PROVIDED TO ERBE FOR A MORE IN DEPTH EXAMINATION.). IT IS UNKNOWN IF THE HOLE EXISTED UPON OPENING THE PACKAGE, AFTER BEING PASSED THROUGH THE ENDOSCOPE BUT PRIOR TO ACTIVATION, OR IT OCCURRED UPON/AFTER ACTIVATION (NOTE: THE INSTRUCTIONS FOR THE PROBE STATES THAT BEFORE USE, THE INSULATION MUST BE CHECKED FOR DAMAGE AND MUST NOT BE USED IF IT IS DAMAGED. IT ALSO STIMULATES THAT THE PRODUCT MUST BE PROTECTED FROM ANY FORM OF MECHANICAL DAMAGE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT REVEALED THAT THE PRODUCTION PROCESS AND THE FINAL INSPECTIONS/TESTS MET SPECIFICATIONS. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). THERE IS NO INDICATION OF A MANUFACTURING ISSUE NOR ANY INDICATION OF A DESIGN DEFICIENCY. ANNUALLY ON AVERAGE 4,000 TO 5,000 PRODUCTS OF THIS TYPE ARE SOLD WORLDWIDE. NO SIMILAR INCIDENTS HAVE BEEN REPORTED INVOLVING THIS PRODUCT (I.E. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. THERE ARE MANY POSSIBLE SCENARIOS INVOLVING THIS TYPE OF ISSUE. THE APC PROBE COULD HAVE BEEN DAMAGED WHEN PASSED THROUGH THE ENDOSCOPE, ETC. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE DAMAGE TO THE PRODUCT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    A PRODUCT ISSUE WAS REPORTED INVOLVING AN APC PROBE DURING AN ENDOSCOPIC INTERVENTION. THE APC PROBE WAS USED WITH AN ARGON PLASMA COAGULATOR (APC) ELECTROSURGICAL UNIT (ESU) SYSTEM. NO SETTINGS WERE PROVIDED. WHEN THE PROBE WAS ACTIVATED, A BREACH (HOLE) WAS NOTICED IN THE TUBING AT THE BLACK MARK THAT WAS CLOSEST TO THE TIP CAUSING THE PROBE TO HAVING TWO COAGULATION BEAMS (ONE AT THE TIP AS INTENDED AND THE OTHER WHERE THE BREACHED OCCURRED). NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060941 ERBE APC FILTER INTEGRATED SIDE FIRE PROBE ARGON PLASMA COAGULATION PROBE GEI ERBE ELEKTROMEDIZIN GMBH 172497

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown