BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CRUSHING FORCEPS, SGL. ACTION JAWS

    MDR report key: 17079695 · Received June 7, 2023

    Report

    Report Number
    9610617-2023-00912
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    September 27, 2017
    Report Date
    June 7, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OCZ
    PMA / PMN Number
    K950434
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 20-0074 CORRECTIVE ACTION 6. THE MOVABLE JAW IS BROKEN ON BOTH HINGE SIDES. THE FRACTURE SURFACES SHOW THE TYPICAL APPEARANCE OF AN OVERLOAD FRACTURE AND ARE LOCATED AT THE POINT EXPECTED FOR A MECHANICAL OVERLOAD. 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 STONE CRUSHING FORCEPS, SGL. ACTION JAWS. ACCORDING TO THE INFORMATION RECEIVED, DURING MANUAL LITHOTRIPSY FOR BLADDER STONE CASE, MOBILE JAW BROKE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587138 STONE CRUSHING FORCEPS, SGL. ACTION JAWS STONE CRUSHING FORCEPS, SGL. ACTION JAWS OCZ KARL STORZ SE & CO. KG 27074B WT01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other