BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 3031774 · Received April 2, 2013

    Report

    Report Number
    2955842-2013-01095
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP REMAINED INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT DAMAGE TO THE MAIN TUBE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS EVENT. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND DURING THE INSPECTION NO ISSUES WERE NOTED. THE INITIAL REPORTER INDICATED THAT THE SURGEON WAS PERFORMING A DA VINCI SI URETERAL REIMPLANTATION PROCEDURE WHEN THE CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT DURING THE SURGICAL PROCEDURE AND THAT IT IS UNKNOWN AS TO WHAT CAUSED THE CABLE ON THE INSTRUMENT TO BREAK. THE INITIAL REPORTER INDICATED THAT NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE CABLE FRAGMENT FROM THE PATIENT AND THAT THE FRAGMENT WAS RECOVERED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER HAS DENIED THAT THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO ANY POST- SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. NO OTHER INFORMATION WAS PROVIDED. 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. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI URETERAL REIMPLANTATION PROCEDURE, ONE OF THE CABLES AT THE END OF THE CLAMP ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE BROKEN PIECE OF CABLE WAS RETRIEVED AND 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
    133677 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10110503 586

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention DA VINCI SI SURG. SYS., INSTRUMENTS, ACCSS & ESU.