BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP-FIT PADDLE BLADE ACCESSORY

    MDR report key: 3628105 · Received February 14, 2014

    Report

    Report Number
    2955842-2014-00885
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K990144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL INC (ISI), CONTACTED THE PERI-OPERATIVE MANAGER AT THE HOSPITAL AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. SHE INDICATED THAT THE INSTRUMENT WAS INSPECTED AS PER THEIR NORMAL PROCESS BY THE SURGICAL TECHNICIAN AND THAT THE INSTRUMENT ACCESSORY WAS IN USE FOR LESS THAN 10 MINUTES BEFORE IT FELL OFF OF THE HANDLE. THE PERI-OPERATIVE MANAGER STATED THAT THE CAUSE OF THE BLADE ACCESSORY FALLING OFF IS UNKNOWN. SHE STATED THAT THE INSTRUMENT WAS BEING USED IN THE NORMAL FASHION, WITH NO ADDED SPEED OR FORCE, AND DENIED ANY INSTRUMENT COLLISIONS. SHE ALSO STATED THAT THE SURGEON WAS ABLE TO RETRIEVE THE SNAP-FIT BLADE INTACT AND DENIED ANY X-RAYS WERE PERFORMED AS A RESULT OF THE REPORTED EVENT. SHE ALSO DENIED THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS, OTHER THAN PROLONGED ANESTHESIA. THE SNAP-FIT PADDLE BLADE ACCESSORY WAS RETURNED AND EVALUATED. THE INSTRUMENT ACCESSORY WAS UNABLE TO BE TESTED DUE ITS DESIGN AS A SINGLE USE ACCESSORY. IN NORMAL USE, WHEN THE SNAP FIT BLADE ACCESSORY IS REMOVED FROM THE INSTRUMENT, THE CONNECTIONS BECOME BENT, SO THAT THE BLADE ACCESSORY IS NOT USED AGAIN. THEREFORE, THERE IS NO WAY TO CONFIRM, NOR REPLICATE THE REPORTED EVENT. NO OTHER DAMAGE WAS FOUND WITH THE RETURNED BLADE ACCESSORY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SNAP-FIT PADDLE BLADE ACCESSORY DISLODGED FROM THE SNAP-FIT SCALPEL INSTRUMENT AND FELL INTO THE PATIENT. PER THE INFORMATION PROVIDED, THE INSTRUMENT ACCESSORY WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS USING THE SNAP-FIT SCALPEL INSTRUMENT WITH THE SNAP-FIT PADDLE BLADE ACCESSORY INSTALLED TO DISSECT TISSUE ON THE UTERUS, THE BLADE ACCESSORY FELL OFF THE HANDLE AND INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE INSTRUMENT ACCESSORY LAPAROSCOPICALLY. THE TIME UNDER ANESTHESIA WAS REPORTED TO BE PROLONGED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98798 SNAP-FIT PADDLE BLADE ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400158-01 MBKH740

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR