BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCEPS MCL-S21 RIGHT SATALOFF HEART

    MDR report key: 7046122 · Received November 20, 2017

    Report

    Report Number
    2523190-2017-00145
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 15, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; DURING THE ANALYSIS OF THE RETURNED USED FORCEPS, IT IS NOTICED THAT THE TIPS IS BROKEN, WITHOUT KNOWING HOW THE INSTRUMENT WAS USED DURING USE, THE CAUSE IS UNDETERMINED. THE COMPLAINT REPORT IS CONFIRMED; DAMAGED WORN. DHR REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. COMPLAINTS HISTORY: NO ADVERSE TREND - FIRST OCCURRENCE OF THIS RISK FOR THIS DEVICE. CONCLUSION: THERE WERE FORCEPS, RETURNED USED/PROCESSED, SHOWING WEAR AND A BROKEN TIP. THE COMPLAINT REPORT HAS BEEN CONFIRMED. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE IN PATIENT'S AIRWAY DURING SURGICAL PROCEDURE. SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE. PATIENT INJURY WAS REPORTED AND MEDICAL INTERVENTION WAS REQUIRED. THE EVENT LEAD TO SURGICAL DELAY, IT IS UNKNOWN FOR HOW LONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825889 FORCEPS MCL-S21 RIGHT SATALOFF HEART PFM11 KAE INTEGRA YORK, PA INC. 140901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention