BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15 CUDA BENDABLE TO 30

    MDR report key: 4093256 · Received September 15, 2014

    Report

    Report Number
    4093256
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 3, 2014
    Manufacturer
    CONMED CORP.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RISK RECEIVED A CALL FROM OPERATING ROOM THAT A PIECE OF THE SHAVER BROKE OFF WHILE THE SURGEON WAS PERFORMING A KNEE SCOPE. OPERATING ROOM SUPERVISOR REPORTED "IT WAS ORIGINALLY THOUGHT A PIECE OF THE SHAVER BROKE OFF INSIDE THE PATIENT" BECAUSE THE SURGEON REPORTED HE SAW SOMETHING SHINY IN THE KNEE ON THE MONITOR. HE WAS UNABLE TO LOCATE THE OBJECT VISUALIZING THROUGH THE SCOPE. HE ORDERED AN XRAY WHICH DID NOT SHOW ANY FOREIGN OBJECT. THE DEVICE WAS TAKEN APART IN THE ROOM BUT THERE WAS NO EVIDENCE OF ANYTHING MISSING OR BROKEN OFF. THE CONSENSUS WAS THE DEVICE DID MALFUNCTION AND THE SHINY OBJECT THE SURGEON SAW MIGHT HAVE BEEN A REFLECTION FROM THE LIGHT SOURCE. THE DEVICE WAS REMOVED FROM SERVICE AND PICKED UP BY PATIENT SAFETY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SURGEON DID DOCUMENT IN HIS OP REPORT HOW HE AND THE SCRUB TECH THOUGHT THEY SAW SOMETHING SHINY BUT TRIED TO GRAB IT AND IT MOVED. HE WAS UNABLE TO RETRIEVE IT. HE CONTINUED HIS SURGERY AND DID LOOK AGAIN BUT WAS UNSUCCESSFUL IN LOCATING IT. THE KNEE WAS IRRIGATED AND PURGED BUT DID NOT SEE ANYTHING COME OUT. AN X-RAY WAS TAKEN. DISCLOSURE TO PATIENT FAMILY PERFORMED OF COMPLICATION. RISK IS REPORTING THIS AS A PATIENT SAFETY CONCERN AND POSSIBLE RETAINED FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568709 15 CUDA BENDABLE TO 30 CUDA SHAVER HRX CONMED CORP. 567244

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR