BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER REVOLUTION DSP FORCEPS

    MDR report key: 11708298 · Received April 22, 2021

    Report

    Report Number
    3003398873-2021-00027
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 12, 2021
    Report Date
    July 15, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    UDI-DI
    07612717070622
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE FORCEPS SAMPLE WAS RECEIVED IN OPENED ORIGINAL PACKAGING INCLUDING THE COVER FOIL. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS. IT WAS FOUND THAT THE SHAFT AND GRASPING ARMS ARE BENT AND THE FORCEPS SHOWS SURGERY RESIDUALS. DUE TO THE CONDITION OF THE SAMPLE THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE BENDING DOES NOT ALLOW A DETAILED EXAMINATION OF THE ROOT CAUSE FOR THE REPORTED ISSUE WITH OPENING. DUE TO THE SURGERY RESIDUALS IT CAN BE ASSUMED THAT DEVICE WAS BENT DURING USE. THE ROOT CAUSE FOR THE REPORTED OPENING ISSUE WITH FORCEPS COULD NOT BE DETERMINED CONCLUSIVELY DUE TO INSUFFICIENT SAMPLE. THE BENDING WAS MOST POSSIBLY CAUSED DURING HANDLING. A MANUFACTURING OR DESIGN RELATED ROOT CAUSE FOR THE DAMAGE OF THE COMPLAINED DEVICE HAS NOT BEEN IDENTIFIED. THIS COMPLAINT HAS BEEN REVIEWED AND FUTURE DATA WILL BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING AND FURTHER ACTION WILL BE TAKEN, AS APPROPRIATE. AT A MINIMUM, THIS WILL INCLUDE COMPLETING REVIEWS OF COMPLAINT CLASS REPORT LEVELS ON A MONTHLY BASIS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT AN OPHTHALMIC FORCEPS TIP WAS NOTED TO BE BENT AND WOULD NOT OPEN DURING A VITRECTOMY WITH MEMBRANE PEEL SURGERY TO THE LEFT EYE. AN ALTERNATE FORCEPS WAS OBTAINED IN ORDER TO PERFORM THE SURGERY. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603894 GRIESHABER REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA 13P6J0 07612717070622

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR