BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW LONG FENESTRATED GRASPER TIP REUSABLE

    MDR report key: 6752193 · Received July 28, 2017

    Report

    Report Number
    1223422-2017-00118
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    July 4, 2017
    Report Date
    July 7, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Removal / Correction Number
    1223422-07142017-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO MICROLINE SURGICAL FOR MECHANICAL EVALUATION OR INVESTIGATION. ALTHOUGH THE PRODUCT WAS NOT RETURNED FOR AN PRODUCT INVESTIGATION, THIS IS A KNOWN ISSUE. MICROLINE INC., HAS NOTICED AN INCREASE OF REPORTED DEVICES WITH THIS SIMILAR FAILURE. A CORRECTIVE ACTION PLAIN HAS BEEN ISSUED IN EFFORTS TO ADDRESS THE INCREASE OF THESE FAILURES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, DECONTAMINATED AND VISUALLY INVESTIGATED. UPON VISUAL INSPECTION, THIS COMPLAINT HAS BEEN CONFIRMED. THE RETURNED TIP WAS RETURNED WITH A MISSING HEAT SHRINK. (B)(4) HAS NOTICED AN INCREASE OF REPORTED DEVICES WITH THIS SIMILAR FAILURE. A CORRECTIVE ACTION PLAN HAS BEEN ISSUED IN EFFORTS TO ADDRESS THE INCREASE OF THESE FAILURES. THIS IS AN KNOWN ISSUE THAT IS BEING ADDRESSED IN (B)(4). AS PART OF MICROLINE INC CONSTANT PRODUCT IMPROVEMENT, AS OF (B)(6) 2017 ALL MICROLINE INC REUSABLE TIPS WERE RECALLED. ALL OF CUSTOMERS WERE MADE AWARE OF THIS PRODUCT RECALL WHILE THIS ISSUE IS BEING ADDRESSED.

    Description of Event or Problem · 1

    DURING PREP TIME FOR A SURGICAL PROCEDURE THE HEAT SHRINK FROM THE RENEW FENESTRATED GRASPER CRACKED. THE PROCEDURE AND ANESTHESIA TIME WAS EXTENDED BY TEN MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531498 RENEW LONG FENESTRATED GRASPER TIP REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3261 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other