BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, BIPOLAR

    MDR report key: 20517667 · Received October 23, 2024

    Report

    Report Number
    9610617-2024-00399
    Event Type
    Injury
    Date Received
    October 23, 2024
    Report Date
    October 23, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAS
    PMA / PMN Number
    K221893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 6. DUE TO A LACK OF THE PRODUCT (DISCARDED BY USER), AN INVESTIGATION COULD NOT TAKE PLACE. HOWEVER, BASED ON OUR EXPERIENCE AND SIMILAR COMPLAINTS IT IS MOST PROBABLY THAT A USAGE RELATED ERROR (E.G. AN OVERLOAD SITUATION) LED TO THE DESCRIBED FAILURE PATTERN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ( (B)(4) ).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A CUTTING LOOP. WE HAVE BEEN MADE AWARE OF AN EVENT PERTAINING TO A 011160-01 ELECTRODE, BIPOLAR THAT OCCURRED AT WARRINGTON HOSPITAL WHEREBY PATIENT INJURY OCCURRED. THE FOLLOWING WAS REPORTED: DURING A TURBT PROCEDURE THE CONSULTANT PERFORATED THE PATIENT'S BLADDER WALL WHILST USING THE BIPOLAR LOOP. MOST OF THE TUMOUR HAD BEEN REMOVED AND THERE WAS JUST ABIT OF TISSUE LEFT THAT REQUIRED RESECTION, DURING THIS FINAL PASS THE LOOP THE BLADDER PERFORATED. THERE WAS NO FAILURE OF THE LOOP OR ANY OTHER PART OF THE STORZ EQUIPMENT. IT WAS REPORTED THAT THIS INCIDENT WAS DOWN TO LACK OF EXPERIENCE WITH THE EQUIPMENT. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323037 ELECTRODE, BIPOLAR ELECTRODE, BIPOLAR FAS KARL STORZ SE & CO. KG 011160-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other