BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOOK

    MDR report key: 7004407 · Received November 6, 2017

    Report

    Report Number
    3010692967-2017-00013
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    April 27, 2017
    Report Date
    May 9, 2017
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAB
    PMA / PMN Number
    K896554
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    -METHOD: THE ACTUAL DEVICE WAS DISCARDED. STERILE DEVICES FROM THE SAME LOT WERE RETURNED FOR TESTING AND VISUAL EXAMINATION. -RESULTS/CONCLUSIONS: RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENT LOTS MET CURRENT USP AND SURGICAL SPECIALTIES (B)(4) INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. THE RETURNED STERILE SAMPLES FROM THE SAME FINISHED GOOD LOT WERE DUCTILITY TESTED AND VISUALLY REVIEWED. ALL DEVICES MET THE CURRENT REQUIREMENTS FOR THIS SIZE/TYPE NEEDLE/SUTURE DEVICE. -WITHOUT REVIEWING THE ACTUAL DEVICE TO DETERMINE TOOL PLACEMENT, RECEIVING DETAILED INFORMATION REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICE OR THE SURGEON'S TECHNIQUE, A DEFINITIVE ROOT CAUSE FOR THE NEEDLE BREAKING DURING USE CANNOT BE DETERMINED WITH CERTAINTY.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PLACE A DENTAL IMPLANT IN SITE #19 UNDER IV SEDATION, THE PATIENT HAD A CHALLENGING AIRWAY. TO CORRECT THE SITUATION, THE SURGEON ATTEMPTED TO PLACE A TONGUE TRACTION SUTURE TO IMPROVE THE AIRWAY. THE NEEDLE FRACTURED AND WAS RETAINED IN THE TONGUE. AFTER UNSUCCESSFULLY TRYING TO RETRIEVE IT IN THE OFFICE, THE PATIENT WAS TAKEN TO HOSPITAL OR, PLACED UNDER GENERAL ANESTHESIA VIA A NASAL ENDOTRACHEAL TUBE. ONCE PATIENT WAS ASLEEP, PARALYZED AND AIRWAY UNDER CONTROL, THE NEEDLE SEGMENT WAS LOCATED AND REMOVED BY ENLARGING PREVIOUS INCISION. THE NEEDLE WAS REMOVED WITHOUT FURTHER INCIDENT OR INJURY TO THE PATIENT. THE PATIENT WILL BE RE-EVALUATED WHEN SUTURES ARE REMOVED. ADVERSE SEQUELAE REPORTED:PAIN, SWELLING, DECREASED FUNCTION OF THE TONGUE AND DELAY IN INITIAL TREATMENT. THE INCISION MAY LEAVE A POSSIBLE SCAR AND MAY DECREASE SENSATION IN THE AREA DISTAL FROM TO THE INCISION THAT WAS REQUIRED TO REMOVE THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782829 LOOK PLAIN GUT 19MM REV CUTTING NEEDLE/SUTURE GAB SURGICAL SPECIALTIES CORPORATION 554B AAAR758

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention