BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW ENDOCUT SCISSORS TIP REUSABLE

    MDR report key: 6629166 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00066
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 28, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED, DECONTAMINATED AND VISUALLY INVESTIGATED. UPON VISUAL INSPECTION THIS COMPLAINT HAS BEEN CONFIRMED. THE FOLLOWING RETURNED TIPS WERE RETURNED WITH A DEFECTIVE HEAT SHRINK. THE 00130041- 2 CONFIRMED, 00130689- 2 CONFIRMED, 00130280 - 4 CONFIRMED. 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 LAPAROSCOPIC CHOLECYSTECTOMY SURGICAL PROCEDURE, THE HEAT SHRINK FROM THE RENEW ENDOCUT SCISSOR TIP, AND FELL INTO A PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411969 RENEW ENDOCUT SCISSORS TIP REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3141 00130041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention