BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOH MARCRO NEEDLE HOLDER

    MDR report key: 14958126 · Received July 8, 2022

    Report

    Report Number
    9610617-2022-00117
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 4, 2022
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551098127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. WHEN THE AFFECTED PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, AN INVESTIGATION OF THE RETURNED PRODUCT WILL BE CONDUCTED.

    Additional Manufacturer Narrative · 0

    THE CONCERNED 26173KAL MACRO NEEDLE HOLDER WAS RETURNED AND INVESTIGATED BY THE MANUFACTURER. UPON INSPECTION OF THE INSTRUMENT A DAMAGE AT THE DISTAL END COULD BE CONFIRMED. THE TIE ROD IN THE JOINT MECHANISM OF THE MOVABLE JAW IS BROKEN. TWO PARTS OF THE TIE ROD HAVE BEEN BROKEN OFF. FURTHERMORE, THERE ARE IMPRINTS VISIBLE IN THE BACK OF BOTH JAW PARTS OUTSIDE OF THE CLAMPING AREA. THIS INDICATES THAT THE NEEDLE WAS NOT INSERTED IN THE INTENDED AREA BETWEEN THE CARBIDE PLATES OF THE JAW PARTS. AS A RESULT, THE DISTANCE BETWEEN THE JAW PARTS WAS TOO LARGE AND A HIGH LEVERAGE FORCE ON THE JOINT WAS CAUSED. THIS LED TO THE BREAKAGE OF THE TIE ROD IN THE JOINT.

    Description of Event or Problem · 0

    AS PER MANUFACTURER INCIDENT REPORT (B)(4) WE RECEIVED FROM THE FACTORY IN GERMANY: OPERATION: LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. OPERATION EXTENSION: RE-OPERATION TO REMOVE BROKEN PARTS. THEY FELT UNCOMFORTABLE WHEN THEY GRABBED THE SUTURE NEEDLE. AFTER COMPLETING THE SURGERY ON THE PATIENT, THEY FOUND THAT THE JAW OF 26173KAL WAS BROKEN. THEY PERFORMED AN X-RAY EXAMINATION. THEN, BECAUSE HE FOUND A BROKEN FRAGMENTS, HE RECOVERED THEM BY RE-OPERATION. AT PRESENT, THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105431 KOH MARCRO NEEDLE HOLDER NEEDLE HOLDER, REUSABLE GCJ KARL STORZ SE & CO. KG 26173KAL TO01 04048551098127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention