BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-STAY 8/PK

    MDR report key: 5613341 · Received April 27, 2016

    Report

    Report Number
    1216677-2016-00002
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    January 7, 2016
    Report Date
    February 2, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE E-COMPLAINT NUMBER (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED, X-REVIEW DHR, X-INSPECT RETURNED SAMPLES, INSPECT STOCK PRODUCT. ANALYSIS AND FINDINGS: DHR REVIEW OF WO#147552 SHOWS PN 3205-8G WAS MADE IN MAY 2013 AND WAS MANUFACTURED, ASSEMBLED, INSPECTED AND TESTED PER ESTABLISHED PROCEDURES AND THERE WERE NO ISSUES IDENTIFIED IN THE DEVICE(S). THESE PRO-STAY 8PK STAYS ARE MEANT FOR GENTLE RETRACTION AND IS LABELED WITH PN 828-3290 THAT STATES "NOTICE: DO NOT USE FORCEPS. USE GENTLE RETRACTION". 71 FINISHED UNITS WERE MANUFACTURED IN THIS LOT. REVIEW OF PART HISTORY SHOWS FROM 1999 THE PN 828-3290 LABEL HAS BEEN IN USE. REVIEW OF COMPONENT PARTS SHOWS: PN 720-3205 MOLDED HOOK FROM LOT 126133 OF TOTAL QUANTITY (B)(4) WERE MOLDED IN 2012 AND HAVE BEEN USED IN 14 OTHER PN 3205-8G LOTS. THERE WAS ONE OTHER COMPLAINT FROM LOT IN SEP 2014 WHERE THE "STAY TIP SEPARATED FROM THE STAY TAIL". THAT INVESTIGATION CONFIRMED THAT MORE THAN 8.8LBF FORCE WAS USED TO PULL APART THE STAY HEAD FROM THE TAIL. NO TIPS WERE BROKEN IN THAT CASE. IN 2011 A SIMILAR COMPLAINT FOR BROKEN HOOK CC#776 WAS INVESTIGATED WHICH CONFIRMED AN EXCESSIVE FORCE OF 18.5 LBF OR MORE CAUSED THE TIP TO BREAK. CLOSER INVESTIGATION OF RETURNED PARTS WAS PERFORMED UNDER MAGNIFICATION. THE SURFACES WHERE THE TIPS BROKE APPEAR UNEVEN AND ARE NOT CLEAN CUTS, CONFIRMING APPLICATION OF EXCESS FORCE DURING RETRACTION. ROOT CAUSE: AN EXCESSIVE AMOUNT OF FORCE APPLIED CAUSED THE MOLDED STAY TIPS TO BREAK. CORRECTION AND/OR CORRECTIVE ACTION: FORMAL TRACK AND TREND PER ESTABLISHED LONESTAR PROCEDURES. CORRECTIVE ACTION LEVEL: NONE. REASON: WARNING LABEL IS INCLUDED IN THE PRODUCT.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT YET BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WITH INVESTIGATION FINDINGS. (B)(4).

    Description of Event or Problem · 1

    "TWICE DURING OPERATIONS THE PLASTIC HOOK OF THE ELASTIC STAYS BROKE AND THE LITTLE PARTS FELL INTO THE WOUND THUS CAUSING ADDITIONAL PROCEDURES TO REMOVE THEM FROM THE BODY ." REF E-COMPLAINT (B)(4).

    Description of Event or Problem · 1

    "TWICE DURING OPERATIONS THE PLASTIC HOOK OF THE ELASTIC STAYS BROKE AND THE LITTLE PARTS FELL INTO THE WOUND THUS CAUSING ADDITIONAL PROCEDURES TO REMOVE THEM FROM THE BODY ." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269101 PRO-STAY 8/PK ELASTIC STAYS PRO-STAY 8/PK GDG COOPERSURGICAL, INC. 3205-8G 147562

    Patients

    Seq Age Sex Outcome Treatment
    1