BEUDAMED
    FDA Adverse Event Other Summary report: N

    "RE-NEW" LAPAROSCOPIC INSTRUMENTS

    MDR report key: 3224406 · Received July 10, 2013

    Report

    Report Number
    1223422-2013-00020
    Event Type
    Other
    Date Received
    July 10, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE LOOSE REF 3152 WAS RETURNED, DECONTAMINATED AND INVESTIGATED. THE RETURNED TIP WAS VISUALLY INSPECTED AND NO TOOL MARKS OR SIGNS OF MISUSE WERE FOUND. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR LOT NUMBER 00111455. NO ISSUES WERE FOUND WITH THE DEVICE HISTORY RECORD. THE RETURNED TIP WAS RECEIVED WITH THREE RENEW HANDPIECES HAVING S/N (B)(4). THE TIP WAS THREADED ONTO THE THREE HANDPIECES WITHOUT ANY ISSUES. THE RETURNED TIP MAY ARC WHEN USED WITH RETURNED HANDPIECE DUE TO THE SEVERE O-RING DAMAGE ON THEM, CONFIRMING THE COMPLAINT. THESE HANDPIECES SHOULD NOT BE USED IN ACCORDANCE WITH THE RENEW FAMILY OF LAPAROSCOPIC SERIES 3900 RATCHETED AND NON-RATCHETED HANDPIECES INSTRUCTIONS FOR USE PRECAUTIONS #3 STATE: DO NOT USE THE HANDPIECE IF THE O-RING LOCATED AT THE DISTAL END OF THE SHAFT APPEARS WORN, DAMAGED OR MISSING. THE CAUSE OF THE O-RING DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THERE WAS AN ELECTRIC ARC DURING USED AND THE PERITONEUM OF THE PATIENT WAS BURNED. THE INJURIES ARE NOT SEVERE AND HAVEN'T ENDANGERED THE PATIENT'S LIFE. THE PATIENT IS DOING WELL. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317894 "RE-NEW" LAPAROSCOPIC INSTRUMENTS DISPOSABLE MINI ENDOCUT SCISSORS TIP GEI MICROLINE SURGICAL 3152 00111455

    Patients

    Seq Age Sex Outcome Treatment
    1