BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT

    MDR report key: 17191288 · Received June 23, 2023

    Report

    Report Number
    9610617-2023-00718
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    April 3, 2018
    Report Date
    June 20, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K945101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 EXAMINATION SHOWS THAT THE WELD SEAM BETWEEN THE PIN AND THE HOLDER IS BROKEN. THE PIN IS BENT AND SHOWS STRONG SIGNS OF USE. 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 AN "INSERT". ACCORDING TO THE INFORMATION RECEIVED, THE PIN BROKE OFF DURING THE SURGERY. THE BROKEN PART COULD BE COMPLETELY RECOVERED FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989333 INSERT EXTERNALLY-ANCHORED LAPAROSCOPIC RETRACTOR GCJ KARL STORZ SE & CO. KG 30623ULI PS01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 30623UH HANDLE.| 30623ULI INSERT.| 30623URA OUTER TUBE.| 30623US ROTATING WHEEL FOR BENDING.