BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MICROFORCEPS: ILM.(23 GAUGE / 0.6 MM)

    MDR report key: 17964584 · Received October 19, 2023

    Report

    Report Number
    1222074-2023-00074
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 19, 2023
    Report Date
    December 14, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.
    Product Code
    HNR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, ONE 23 GAUGE DISPOSABLE MICRO-FORCEPS ILM WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED SOME FOREIGN MATERIAL ON THE TIP OF THE INSTRUMENT. FUNCTIONAL TESTING DEMONSTRATED THAT THE MOVEMENT OF THE TIP WAS COMPROMISED. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS WERE REPORTED ON THIS SPECIFIC LOT PRIOR TO THIS CASE OR SINCE. IT SHOULD BE NOTED THAT, ON SOME OCCASIONS, WHEN MEASUREMENTS OF DIFFERENT PARTS OF THE INSTRUMENT ARE CLOSE TO THEIR MAXIMUM OR MINIMUM TOLERANCE, THE MOVEMENT OF THE TIP CAN BE COMPROMISED. UNFORTUNATELY, THIS IS INHERENT TO THE DESIGN OF THE ILM FORCEPS. THE INTRODUCTION OF SURGICAL REMAINS ON THE TIP AND INSIDE THE CAPILLARY DURING USE MAY AMPLIFY THE DETERIORATED PERFORMANCE. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. IN ORDER TO ELIMINATE THE MOVEMENT ISSUES WITH THE ILMD MICRO-FORCEPS, AN INVESTIGATION WAS INITIATED TO EXPLORE THE OPPORTUNITIES FOR IMPROVEMENT. CORRECTIVE ACTIONS HAVE BEEN DETERMINED AND WILL BE IMPLEMENTED SHORTLY (DTP 2023-410 - IMPROVE RUNNING EDGE ON ILMD RPPS FOR SMOOTH MOTION). THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODE AS REPORTED SC-MOVEMENT-PROLONGED RELATED TO COMPARABLE MICRO-FORCEPS. PLEASE NOTE THAT WHILE THE 2023 INCIDENT NUMBERS ARE UP TO DATE, THE 2023 DISTRIBUTION FIGURES ARE FROM APRIL 25TH 2023. AS THESE PRODUCTS ARE STILL BEING DISTRIBUTED, THE ACTUAL NUMBER OF DEVICES IN THE MARKET IS HIGHER. THE INCIDENT RATE IS THEREFORE IN FACT LOWER. PLEASE NOTE THAT MOVEMENT RELATED COMPLAINTS ON ILMD MICRO-FORCEPS ARE USUALLY NOT CONSIDERED REPORTABLE, SINCE THE PATIENT HARM THAT MAY OCCUR FROM IT (RETINAL TEAR) IS CLASSIFIED AS A MINOR HARM IN OUR GLOBAL HARMS LIST (RPRT 30457500 REV 4.0). THIS PARTICULAR COMPLAINT WAS MERELY REPORTED, BECAUSE THE SURGERY HAD BEEN PROLONGED WITH MORE THAN 30 MINUTES.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE IMPLEMENTED UNTIL THE INVESTIGATION HAS BEEN COMPLETED. IN CASE OF A PRODUCT RETURN, THE DEVICE WILL BE INVESTIGATED, OTHERWISE WE WILL REVIEW THE DEVICE HISTORY RECORD, AND/OR ANY LOG FILES IF AVAILABLE, OR TRY TO REPLICATE THE PROBLEM ON SIMILAR PRODUCT. AS INVESTIGATIONS ON THE ACTUAL PRODUCT OR REPRESENTATIVE SAMPLE OF A BATCH MAY ALTER THE DEVICE, WE REQUEST TO INFORM US WITHIN 7 DAYS AFTER SUBMISSION OF THIS REPORT, IN CASE THE INVESTIGATIONS THAT ALTER THE DEVICE SHOULD BE HALTED UNTIL APPROVAL OF THE NCA, AS PER ARTICLE 89 OF EU-MDR.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE FORCEPS WERE NOT WORKING CORRECTLY. THE FORCEPS WOULD HOOK TOGETHER AND THE SURGEON CANNOT OPEN AND CLOSE THE TIP. THIS ISSUE MADE THE SURGERY MORE DIFFICULT SINCE THE SURGEON HAD TO MOVE DIFFERENTLY INSIDE THE EYE TO COUNTERACT THE FORCEPS. LATER, A NEW FORCEPS WAS USED. SURGERY WAS PROLONGED > 30 MIN. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE FORCEPS WERE NOT WORKING CORRECTLY. THE FORCEPS WOULD HOOK TOGETHER AND THE SURGEON CANNOT OPEN AND CLOSE THE TIP. THIS ISSUE MADE THE SURGERY MORE DIFFICULT SINCE THE SURGEON HAD TO MOVE DIFFERENTLY INSIDE THE EYE TO COUNTERACT THE FORCEPS. LATER, A NEW FORCEPS WAS USED. SURGERY WAS PROLONGED MORE THAN 30 MIN. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86863 DISPOSABLE MICROFORCEPS: ILM.(23 GAUGE / 0.6 MM) OPHTHALMIC SOFT-TISSUE SURGICAL FORCEPS, PROBE-LIKE, SINGLE-USE HNR D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. 3459-*-*-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown