BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW TRADITIONAL MARYLAND DISSECTOR FORCEPS

    MDR report key: 6903927 · Received September 29, 2017

    Report

    Report Number
    1223422-2017-00124
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    July 27, 2017
    Report Date
    September 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    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 DEFECTIVE HEAT SHRINK. MICROLINE INC., 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. (B)(4).

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE USER NOTICED THAT THE HEAT SHRINK TUBE CAME OFF. TWO THIRDS OF THE HEAT SHRINK TUBE WAS FOUND IN THE PATIENT. ONE-THIRD WAS MISSING. THE USER HAS NO IDEA WHEN AND HOW THE HEAT SHRINK TUBE CAME OFF. THE ANESTHESIA AND PROCEDURE TIME WAS NOT EXTENDED THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683737 RENEW TRADITIONAL MARYLAND DISSECTOR FORCEPS MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3351 00128259

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention