BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW MODIFIED RAPTOR GRASPER FORCEPS TIP REUSABLE

    MDR report key: 6629209 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00082
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    April 6, 2017
    Report Date
    April 27, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO MICROLINE SURGICAL. THE REPORTED DEVICE WAS DISCARDED AT THE HOSPITAL.. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. 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. REF CAPA (B)(4).

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE HEAT SHRINK FROM THE RENEW MODIFIED RAPTOR GRASPER FORCEPS TIP FELL INTO THE ABDOMEN OF THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. THE PROCEDURE AND ANESTHESIA TIME WAS NOT EXTENDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412673 RENEW MODIFIED RAPTOR GRASPER FORCEPS TIP REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3291 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention