BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINOCHIETTO RIB SPREADER 65X65MM BLDS

    MDR report key: 8356202 · Received February 20, 2019

    Report

    Report Number
    9610612-2019-00106
    Event Type
    Death
    Date Received
    February 20, 2019
    Date of Event
    January 19, 2019
    Report Date
    February 28, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPDATED.

    Description of Event or Problem · 0

    FURTHER CLARIFICATION RECEIVED ON (B)(6)2019 : DATE OF SURGERY IN THE EMERGENCY ROOM WAS 19JAN2019; THIS WAS ALSO WHEN DEATH OCCURRED, DURING THE SURGERY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INSTRUMENT IS IN A NEW CONDITION, NO DEVIATION CAN BE FOUND WITH THE NAKED EYE. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY (PANASONIC). NO DEVIATION COULD BE FOUND AT THE MINT INSTRUMENT, NEITHER DURING FUNCTIONAL TEST, NOR DURING VISUAL INSPECTION. ONLY SMALL SCRATCHES CAN BE FOUND AT THE TIP OF THE BLADES, MOST LIKELY CAUSED BY VIBRATIONS IN A CLOSED STATE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONALE: THE INSTRUMENT IS ACCORDING TO THE SPECIFICATIONS, NO DEVIATIONS CAN BE FOUND AT THE PROVIDED INSTRUMENTS. FURTHERMORE, THE CONTACT PERSON AT THE HOSPITAL CONFIRMED THAT THE RETRACTOR WAS NOT THE CAUSE OF THE PATIENT'S DEATH BUT THE GUNSHOT-INJURY. NO CAPA IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIB SPREADER FAILED INTRAOPERATIVELY. DURING A TRAUMA CASE (GUNSHOT WOUND TO THE CHEST) WHEN PREPARING TO USE THE FINOCHIETTO RETRACTOR (RIB SPREADER) IT WAS NOTICED THE RETRACTOR WAS ASSEMBLED INCORRECTLY, MAKING IT UNUSABLE. THE RETRACTOR WAS DISASSEMBLED BEFORE STERILIZATION, AND WAS NOTICED WHEN THE STERILE TRAY WAS OPENED. THE ROTATION KNOB WAS ON THE PATIENT SIDE OF THE RETRACTOR. AS A RESULT THE SURGEON NEEDED TO CRACK THE PATIENT'S STERNUM. IT WAS REPORTED THE PATIENT DIED DUE TO THE FATAL GUNSHOT WOUND AND NOT BECAUSE OF THE RETRACTOR. PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146413 FINOCHIETTO RIB SPREADER 65X65MM BLDS CARDIO-THORACIC SURGERY GAD AESCULAP AG FB804R 52482522

    Patients

    Seq Age Sex Outcome Treatment
    1 Death