BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOPKINS RIGID LAPAROSCOPE

    MDR report key: 17135777 · Received June 15, 2023

    Report

    Report Number
    9610617-2023-00124
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 15, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    EOB
    UDI-DI
    04048551193822
    PMA / PMN Number
    K945788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER MANUFACTURE EVALUATION: THE IFU WARNS THE RISK OF INJURY THE HIGHLY CONCENTRATED LIGHT ENERGY CAN CAUSE THE DISTAL END, THE LIGHT PORT, ADJACENT COMPONETS AND TISSUE IN FRONT OF THE LIGHT EMISSION WINDOW TO HEAT UP THIS CAN CAUSE BURNS TO THE PATIENT, USER AND SURGICAL ACCESSORIES. DURING THE EXAMINATION OF THE OPTIC IN OUR POSSESSION, WE WERE ABLE TO DETECT LEAKAGE OF THE ROD LENS SYSTEM DUE TO A CHEMICALLY ATTACKED SOLDER SEAM. THE CHEMICAL ATTACK OF THE DISTAL SOLDER SEAM CAUSED LEAKAGE, RESULTING IN MOISTURE PENETRATION INTO THE ROD LENS SYSTEM. FURTHERMORE, VARIOUS MECHANICAL DAMAGES IN THE FORM OF SCRATCHES, IMPACT MARKS AND MECHANICAL MATERIAL REMOVAL CAN BE OBSERVED IN THE DISTAL AREA. THE AFOREMENTIONED DAMAGE IS DUE TO CLINICAL USE AND NOT TO A PRODUCTION DEFECT. FURTHERMORE, THE AFOREMENTIONED DAMAGES ARE NOT CAUSALLY RESPONSIBLE FOR THE RESULTING BURN OF THE PATIENT. IN CONNECTION WITH THIS CASE, THERE IS A 495NAC LIGHT CABLE USED IN COMBINATION (ZC 200963353 MDR23-125 972992) WHICH, ACCORDING TO THE CUSTOMER, WILL NOT BE RETURNED BECAUSE THIS CABLE WAS DISPOSED OF BY THE USER. FOR THIS REASON, A MORE DETAILED INVESTIGATION AND ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. A POSSIBLE CAUSE FOR THE STRONG HEATING OF THE OPTICS AND THE RESULTING BURNING OF THE PATIENT MAY BE THE USE OF AN UNBRANDED LIGHT SOURCE, A LIGHT OUTPUT THAT IS SET TOO HIGH, OR SOILING OF THE LIGHT CONNECTION ON THE OPTICS SIDE. FURTHERMORE, A TOO SMALL DISTANCE TO THE SURROUNDING TISSUE CAN CAUSE A BURN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ON-GOING. PRODUCT HAS BEEN RETURNED FOR EVALUATION. PHOTOGRAPHS OF TELESCOPE SHOW GOUGING AROUND DISTAL END, WITH CHIPPED ROD LENS. DISCOLORATION AROUND LIGHT FIBERS ON LIGHT TAPER. NO SIGNS OF TEMPERATURE DEFECT. SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EVENT WITH THE 7230AA HOPKINS TELESCOPE 0 DEGREE, 4MM. ACCORDING TO THE INFORMATION RECEIVED, WHILE USING THE SCOPE ON A PATIENT, THE SCOPE OVERHEATED INJURING THE PATIENT. PATIENT SUFFERED WHAT APPEARED TO BE THERMAL BURN 1ST DEGREE. PER THE FACILITY THE SCOPE WAS USED DURING THE ENTIRE SURGICAL PROCEDURE, APPROXIMATELY 5 HOURS. THE PATIENT SUFFERED WHAT APPEARED TO BE A THERMAL BURN 1ST DEGREE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EVENT WITH THE 7230AA HOPKINS TELESCOPE 0 DEGREE, 4MM. ACCORDING TO THE INFORMATION RECEIVED, WHILE USING THE SCOPE ON A PATIENT, THE SCOPE OVERHEATED INJURING THE PATIENT. PATIENT SUFFERED WHAT APPEARED TO BE THERMAL BURN 1ST DEGREE. PER THE FACILITY THE SCOPE WAS USED DURING THE ENTIRE SURGICAL PROCEDURE, APPROXIMATELY 5 HOURS. THE PATIENT SUFFERED WHAT APPEARED TO BE A THERMAL BURN 1ST DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024430 HOPKINS RIGID LAPAROSCOPE 0 DEGREE,4MM,18CM EOB KARL STORZ SE & CO. KG 7230AA 04048551193822

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other 495NA