BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3081419 · Received April 26, 2013

    Report

    Report Number
    2955842-2013-01421
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT WAS RETURNED WITH THE YAW PULLEY BOSS FEATURE BROKEN OFF. THE BROKEN FRAGMENT WAS NOT RETURNED TO INTUITIVE SURGICAL INC. (ISI) FOR EVALUATION. THE MISSING FRAGMENT MEASURED APPROXIMATELY .060 DIAMETER BY .080 LONG. THE BOSS FEATURE THAT RETAINS THE CONDUCTOR CAP IN PLACE WAS FOUND TO BE FRACTURED AT ITS BASE. THE CONDUCTOR CAP WAS OBSERVED TO BE LOOSE AND WAS ABLE TO BE PULLED OUT OF DISTAL CLEVIS AS A RESULT OF THE BREAKAGE. THE BOSS FEATURE ON THE OPPOSITE SIDE WAS INTACT AND NO DAMAGE WAS OBSERVED ON THE DISTAL CLEVIS. ON (B)(6) 2013, ISI CONTACTED THE CLINICAL COORDINATOR AT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CLINICAL COORDINATOR INDICATED THAT THE PERMANENT CAUTERY HOOK INSTRUMENT WAS INSPECTED PRIOR TO USE AND THE INSTRUMENT WAS USED DURING THE ENTIRE SURGICAL PROCEDURE INVOLVING THE PATIENT'S GALLBLADDER. SHE INDICATED THAT THE DEVICE DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE AND NO X-RAYS WERE PERFORMED ON THE PATIENT TO LOCATE THE BROKEN INSTRUMENT PIECE. ON (B)(6) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE REPORTED SURGICAL PROCEDURE. THE CSR INDICATED THAT AT THE END OF THE SURGICAL PROCEDURE THE BED SIDE ASSISTANT SUCCESSFULLY RETRIEVED THE FRAGMENT FROM THE PATIENT USING AN UNSPECIFIED LAPAROSCOPIC INSTRUMENT THROUGH AN EXISTING PORT SITE. THE CSR STATED THAT THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS BECAUSE OF THE REPORTED EVENT AND THE PATIENT IS CURRENTLY DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF NOTICED A FRAGMENT FROM THE PERMANENT CAUTERY HOOK INSTRUMENT HAD BROKEN OFF AND FELL INTO THE PATIENT. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED AND THE SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180921 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10130115 201

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU