BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3953865 · Received July 23, 2014

    Report

    Report Number
    2955842-2014-04504
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION FOUND THE INSTRUMENT TUBE EXTENSION HAD PAD PRINTING REMOVED. THE DAMAGED AREA MEASURED APPROXIMATELY .102 X .290. ADDITIONAL OBSERVATION DURING FAILURE ANALYSIS FOUND THE MAIN TUBE HAD WHITE SUBSTANCE ON THE DISTAL END OF THE MAIN TUBE. FAILURE ANALYSIS CONCLUDED THE INSTRUMENT MAY HAVE BEEN NEXT TO AN INSTRUMENT WITH THE OLD POLYCARBONATE HOUSING COVER WHICH DEGRADES WHEN EXPOSED TO CERTAIN REPROCESSING CONDITIONS AND CAN CONSEQUENTLY TRANSFER ONTO THE SURROUNDING INSTRUMENTS MAIN TUBE. THE MELTED POLYCARBONATE FROM ANOTHER INSTRUMENT HAS LIKELY TRANSFERRED ONTO THE MAIN TUBE OF THIS INSTRUMENT, FORMING A WHITE RESIDUE ON THE MAIN TUBE. THIS COATING WAS SPREAD OUT OVER MORE THAN 10CM BELOW THE TUBE EXTENSION, AND RANDOMLY IN SMALL PATCHES ALL OVER THE MAIN TUBE. THIS LEVEL OF HOUSING DEGRADATION HAS ONLY BEEN CONFIRMED AT ONE SITE, UNIVERSITY OF MIAMI HOSPITAL. THE DEVIATIONS IN REPROCESSING CONDITIONS (SUCH AS INSUFFICIENT RINSING OR INCORRECT CLEANING CHEMICAL CONCENTRATION) INDICATE USER MISHANDLING AND ARE UNIQUE TO THIS SITE. AFTER FURTHER REVIEW THIS RECURRENCE OF THE ALLEGED FAILURE MODE IS NOT EXPECTED TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. BASED ON THIS ADDITIONAL FAILURE ANALYSIS INVESTIGATION INFORMATION, THIS MDR REPORT IS BEING RETRACTED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE PAINT WAS COMING OFF THE MONOPOLAR CURVED SCISSORS INSTRUMENT'S HOUSING AND GETTING ON THE INSTRUMENT SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431279 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470179-04 S10140210 027

    Patients

    Seq Age Sex Outcome Treatment
    1