BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3953849 · Received July 23, 2014

    Report

    Report Number
    2955842-2014-04503
    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 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION FOUND, THE INSTRUMENT HOUSING LASER MARKING HAD BEEN REMOVED. ADDITIONAL FINDINGS DURING FAILURE ANALYSIS ALSO FOUND: THE INSTRUMENT GRIP TIPS ARE BROKEN. ONE OF THE GRIPS TIPS IS BROKEN AND NOT RETURNED WITH THE INSTRUMENT. FAILURE ANALYSIS CONCLUDED BROKEN DAMAGE MAY BE DUE TO MISHANDLING /MISUSE. THE DISTAL END OF THE MAIN TUBE HAD SOME OF THE HOUSING MATERIAL RUBBED OFF FROM ANOTHER INSTRUMENT DURING CLEANING PROCESS. THE AREA OF THE MATERIAL MEASURED APPROXIMATELY 1.95 LONG. NO OTHER DAMAGE WAS FOUND. THE WHITE RESIDUE SEEN ON THE MAIN TUBE WAS MOST LIKELY MELTED-ON FROM THE WHITE HOUSING OF THE OTHER DA VINCI IS4000 INSTRUMENTS. THE WHITE POLYCARBONATE HOUSING STARTED TO DEGRADE AND TRANSFER UNDER CERTAIN REPROCESSING CHEMICAL CONCENTRATIONS, SUCH AS INSUFFICIENT RINSING OR USING THE INCORRECT CHEMICAL CONCENTRATION. THIS FAILURE IS THOUGHT TO BE DUE TO DEVIATIONS IN THE STANDARD REPROCESSING. THIS LEVEL OF HOUSING DEGRADATION HAS ONLY BEEN CONFIRMED AT ONE SITE, (B)(6) 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 OF THIS CASE THE 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.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE PAINT WAS COMING OFF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S HOUSING AND GETTING ON THE INSTRUMENT SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431991 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470205-09 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1