BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW FENESTRATED GRASPER FORCEPS TIPS

    MDR report key: 7002711 · Received November 6, 2017

    Report

    Report Number
    1223422-2017-00127
    Event Type
    Injury
    Date Received
    November 6, 2017
    Report Date
    November 6, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K981389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT POSSIBLE, PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, DECONTAMINATED AND INVESTIGATED. INVESTIGATION FINDINGS REVEALED THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING VISUAL INSPECTION, IT WAS NOTICED THAT THE JAWS OF THE DEVICE WERE BROKEN AT THE HINGE POINT. THE JAWS OF THE DEVICE MAY HAVE BEEN COMPROMISED BECAUSE OF NATURAL WEAR AND TEAR. EXCESSIVE FORCE MAY ALSO BE A FACTOR, IF THE FORCE APPLIED ON THE GRASPER EXCEEDS 9.9LBS THE TIP WILL BREAK. FOR FINAL INSPECTION REQUIREMENTS, ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IMPERFECTIONS. IT IS NOT LIKELY THAT THE DEVICE LEFT MICROLINE INC IN THIS CONDITION.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC APPENDECTOMY SURGICAL PROCEDURE, ONE SIDE OF THE RENEW FENESTRATED GRASPER TIP SNAPPED AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. THE PROCEDURE AND ANESTHESIA TIME WAS EXTENDED FOR 2 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781863 RENEW FENESTRATED GRASPER FORCEPS TIPS MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3222 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention