BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3802910 · Received May 9, 2014

    Report

    Report Number
    2955842-2014-02889
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    September 24, 2013
    Report Date
    April 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE SITE CONCLUDED THAT THE PATIENT'S INJURY WAS CAUSED BY SURGEON USE-ERROR. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. THE MULTI-USE INSTRUMENTS WERE CONFIRMED TO HAVE BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES. NO RELATED SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. DURING THE DA VINCI HYSTERECTOMY PROCEDURE, AN ERROR CODE 23005 OCCURRED ONE TIME. THE SURGICAL STAFF WAS ABLE TO RECOVER IMMEDIATELY FROM THE ERROR CODE AND NO SUBSEQUENT FAULTS OCCURRED UNTIL THE SURGICAL PROCEDURE WAS COMPLETED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, ACCORDING TO THE SITE THE PATIENT'S INJURY WAS CAUSED BY SURGEON USE-ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, AN UNSPECIFIED BIPOLAR INSTRUMENT AUTO-FIRED AND A POSSIBLE PATIENT INJURY OCCURRED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SITE INFORMED HER THAT THE CAUSE OF THE INSTRUMENT AUTO-FIRING WAS DUE TO THE INSTRUMENT CABLE BEING PLUGGED INTO THE WRONG PORT ON THE GENERATOR. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS NOT RECORDED. BASED ON THE OPERATIVE REPORT THE RISK MANAGER INDICATED THAT THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE DA VINCI HYSTERECTOMY PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. ALTHOUGH THE PATIENT DEVELOPED SYMPTOMS OF ABDOMINAL PAIN AND DISTENSION 24 HOURS POST-OPERATIVELY, SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE FOLLOWING DAY ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN, DISTENSION, NAUSEA, AND VOMITING. THE PATIENT WAS EVALUATED AND A PERFORATION MEASURING APPROXIMATELY ONE CENTIMETER WAS FOUND IN THE DISTAL SIGMOID COLON. NO BURN MARKS WERE FOUND AROUND THE BOWEL PERFORATION. THE PERFORATION WAS REPAIRED VIA A PARTIAL SIGMOID COLECTOMY WITH TEMPORARY END COLOSTOMY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE CURRENT STATUS OF THE PATIENT. AFTER THE EVENT OCCURRED, THE SITE QUARANTINED THE DA VINCI SURGICAL SYSTEM INVOLVED WITH THIS COMPLAINT FOR 1 DAY. DURING THAT SAME DAY, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION OF THE SYSTEM AND NO TROUBLE WAS FOUND. THE SITE THEN PLACED THE DA VINCI SURGICAL SYSTEM BACK INTO SERVICE. ACCORDING TO THE RISK MANAGER, THE SITE PERFORMED AN INTERNAL INVESTIGATION OF THE REPORTED EVENT. THE SURGEON FELT AS THOUGH THE BOWEL PERFORATION WAS CAUSED BY THE AUTO-FIRING OF THE INSTRUMENT OR POSSIBLY ARCING. THE SITE WAS UNABLE TO PROVIDE THE NAME, PART , OR LOT OF THE INSTRUMENT THAT MIGHT HAVE POSSIBLY ARCED. THE SURGEON MENTIONED THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD AUTO-FIRED DURING THE DURING THE DA VINCI SURGICAL PROCEDURE ALTHOUGH HER FOOT WAS JUST HOVERING OVER THE ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC). BASED ON THE SITE'S SYSTEM LOGS, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS USED IN 6 SUBSEQUENT SURGICAL PROCEDURES. IN ADDITION, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE REPORTED INSTRUMENT AUTO-FIRING ISSUE BY THE SITE. ALSO, ALTHOUGH ONE NURSE CLAIMED THAT THE BIPOLAR INSTRUMENT CABLE WAS PLUGGED IN INCORRECTLY TO THE ELECTROSURGICAL UNIT (ESU). HOWEVER, ANOTHER NURSE CLAIMED THAT THE BIPOLAR INSTRUMENT CABLE WAS CORRECTLY PLUGGED INTO THE ESU. DURING THE SURGICAL PROCEDURE, THE BIPOLAR ESU SETTING WAS SET TO 40, AND THE MONOPOLAR ESU SETTING WAS SET TO 35 FOR CUT AND COAG. NO INSTRUMENT COLLISIONS WERE REPORTED DURING THE DA VINCI SURGICAL PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, NO INSTRUMENT DAMAGES WERE FOUND OR REPORTED. ACCORDING TO THE RISK MANAGER, THE SITE CONCLUDED THAT THE PATIENT'S INJURY WAS DUE TO SURGEON USE-ERROR AND NOT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM. THE RISK MANAGER ALSO STATED THAT THE INSTRUMENTS USED DURING THE DA VINCI HYSTERECTOMY PROCEDURE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AND THERE HAVE BEEN NO REPORTED COMPLAINTS OR RECURRENCES OF INSTRUMENT AUTO-FIRINGS OR ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280317 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205 M10130530-177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R