BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS

    MDR report key: 22488001 · Received July 12, 2025

    Report

    Report Number
    3003398873-2025-00322
    Event Type
    Injury
    Date Received
    July 12, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. LITERATURE ARTICLE: THE TRANSSCLERAL REMOVAL TECHNIQUE FOR SUBRETINAL PROLIFERATIVE TISSUES DURING VITRECTOMY FOR RHEGMATOGENOUS RETINAL DETACHMENT. JAPANESE JOURNAL OF OPHTHALMOLOGY 23-JAN-2025 (69) 66-73. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTION H.6 AND H.11. SINCE THE COMPLAINT WAS OPENED BASED ON AN ARTICLE IN SCIENTIFIC LITERATURE, NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. NO LOT NUMBER WAS IDENTIFIED WITHIN THE ARTICLE AND THEREFORE WITHIN THIS COMPLAINT, WHICH IS WHY THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. HOWEVER, ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE IDENTIFIED. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED VIA LITERATURE ARTICLE ASSESSMENT OF THE TRANSSCLERAL REMOVAL TECHNIQUE FOR SUBRETINAL PROLIFERATIVE TISSUES DURING VITRECTOMY FOR RHEGMATOGENOUS RETINAL DETACHMENT. AN OPHTHALMIC FORCEPS AND TROCAR WAS USED DURING THE VITRECTOMY SURGERY AND THE PATIENT EXPERIENCED SUBRETINAL HEMORRHAGE, RETINAL PUNCTURE AND PHOTOCOAGULATION WAS DONE FOR THE TREATMENT OF RETINAL PUNCTURE. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN. THIS COMPLAINT IS PERTAINING THE FIVE OF FIVE REPORTS RECEIVED FROM THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679015 GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention| O EDGEPLUS VALVED ENTRY SYSTEM.