BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3250792 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02780
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL INC. (ISI) AND EVALUATED. ENGINEERING EVALUATION DID NOT FIND ANY FRAGMENTS MISSING FROM THE INSTRUMENT. THE PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINED THE CRIMP WAS STILL INSTALLED IN THE INSTRUMENT'S CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE OTHER CABLES OF THE INSTRUMENT'S WRIST DID NOT EXHIBIT ANY DAMAGE. NO OTHER INSTRUMENT DAMAGE WAS FOUND. INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF INDICATED THAT A FRAGMENT FROM THE INSTRUMENT BROKE OFF, FELL INTO THE PATIENT, AND WAS RETRIEVED. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE FRAGMENT WAS RETRIEVED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT. THE SCRUB TECHNICIAN INDICATED THAT SHE PERFORMED A QUICK INSPECTION OF THE PK DISSECTING FORCEPS INSTRUMENT PRIOR TO THE SURGICAL PROCEDURE AND NO ISSUES WERE OBSERVED. THE SURGICAL PROCEDURE WAS NOT RECORDED. THE SURGEON REPORTEDLY USED THE PK DISSECTING FORCEPS INSTRUMENT FOR A SHORT PERIOD OF TIME BEFORE NOTICING PROBLEMS WITH THE DEVICE. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ALSO USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE SCRUB TECHNICIAN DID NOT RECALL OBSERVING ANY INSTRUMENT COLLISIONS DURING THE SURGICAL PROCEDURE. WHEN THE PK DISSECTING FORCEPS INSTRUMENT WAS REMOVED, THE SCRUB TECHNICIAN NOTICED THAT A CABLE WAS STICKING OUT AND TORN UP. THE PK DISSECTING FORCEPS INSTRUMENT WAS REPLACED WITH ANOTHER INSTRUMENT. A SMALL PIECE OF THE CABLE WAS FOUND ON AN UNSPECIFIED SPECIMEN THAT WAS REMOVED FROM THE PATIENT. AN X-RAY WAS TAKEN PER HOSPITAL POLICY AND FOUND TO BE NEGATIVE FOR FOREIGN BODIES. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT A PIECE ABOUT 2-3 MM IN LENGTH WAS MISSING FROM THE TIP OF THE PK DISSECTING FORCEPS INSTRUMENT AND A PIECE OF CABLE WAS ALSO STICKING OUT AT THE END OF THE INSTRUMENT. THE SURGICAL STAFF INDICATED THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT BUT WAS RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352800 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10130131 117

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES