BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOFF PASS-LONG

    MDR report key: 3812878 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-11630
    Event Type
    Injury
    Date Received
    May 15, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GYK
    PMA / PMN Number
    PK934391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED RECLASSIFYING THE EVENT TO A SERIOUS INJURY. UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE EVALUATION OF THE INSTRUMENT REVEALED EXCESSIVE WEAR THROUGHOUT. THE PASSER WAS VERY TIGHT WITHIN THE SHEATH AND WAS DIFFICULT TO REMOVE. EXCESSIVE FRICTION WAS FELT WHEN REMOVING THE PASSER AND CAUSED THE METAL TO SCRAPE. THE SHEATH IS BENT NOT ALLOWING FOR PROPER FIT OF THE PASSER. IT IS LIKELY THAT MANIPULATION OF THE SHEATH OVER TIME RESULTED IN BENDING/POOR FIT. THE DATE OF MANUFACTURE (OR ANOTHER MARKING) IS NOT VISIBLE, HOWEVER; INSTRUMENT APPEARS TO BE OLD. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHUNT PASSER SHEATH IS DEFECTIVE AND METAL ON METAL FRICTION HAS RESULTING IN METAL SHAVINGS. NO PATIENT INJURY AS RESULT OF DEFECT. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED RECLASSIFYING THE EVENT TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290317 HOFF PASS-LONG INSTRUMENT, SHUNT SYSTEM IMPLANTATION GYK CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention