BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3306679 · Received August 26, 2013

    Report

    Report Number
    2955842-2013-03193
    Event Type
    Injury
    Date Received
    August 26, 2013
    Date of Event
    March 8, 2010
    Report Date
    July 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A THERMAL BURN TO A URETER DURING A DA VINCI S SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT. AFTER THE PATIENT'S UTERUS WAS RESECTED AND MORCELLATED, HER PELVIS WAS IRRIGATED. THE OPERATIVE REPORT STATED THAT EXCELLENT HEMOSTASIS WAS NOTED. UPON CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT'S SKIN INCISIONS WERE CLOSED. SHE WAS THEN EXTUBATED AND ESCORTED TO RECOVERY IN EXCELLENT CONDITION. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT EXPERIENCED VAGINITIS AND VAGINAL INFECTIONS ON MULTIPLE OCCASIONS BETWEEN (B)(6) 2010 AND (B)(6), 2012. ON (B)(6) 2012, THE PATIENT HAD AN OFFICE VISIT AND WAS EVALUATED FOR HYDRONEPHROSIS. THE OFFICE VISIT REPORT STATED THAT THE PATIENT HAD AN MRI THAT REVEALED LEFT SIDED HYDRONEPHROSIS. IT IS UNKNOWN WHAT DATE THE MRI WAS PERFORMED. THE OPERATIVE REPORT ALSO STATED THAT THE PATIENT HAS BEEN TOLD THAT SHE HAS HAD HYDRONEPHROSIS IN THE PAST. ON (B)(6) 2012, A CT SCAN WAS PERFORMED ON THE PATIENT'S ABDOMEN AND PELVIS. THE CT SCAN REVEALED SEVERE LEFT-SIDED HYDRONEPHROSIS AND HYDROURETER. NO MASS OR CALCIFICATION WAS OBSERVED. ON (B)(6) 2012, THE PATIENT UNDERWENT A LEFT RETROGRADE PYELOGRAM WHICH REVEALED SIGNIFICANT NARROWING IN THE LEFT URETER AND SEVERE HYDROURETERONEPHROSIS. THE SURGEON INSERTED A LEFT URETERAL STENT. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL. SHE WAS EXTUBATED IN THE OR AND SENT TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT WAS DISCHARGED HOME THAT SAME DAY. ON (B)(6) 2012, THE PATIENT HAD A POST-OPERATIVE VISIT. IT WAS STATED IN THE OFFICE VISIT REPORT THAT THE PATIENT WAS EXPERIENCING PAIN OR BURNING DURING URINATION. THE OFFICE VISIT REPORT ALSO STATED THAT THE PATIENT DENIED OBSERVING BLOOD IN HER URINE AND SHE HAD GOOD SIZE AND STRENGTH TO HER URINARY SYSTEM. IN ADDITION, THE PATIENT FELT THAT SHE WAS EMPTYING HER BLADDER WELL. ON (B)(6) 2013, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED LAPAROSCOPIC LEFT URETERAL REIMPLANT PROCEDURE WITH PSOAS HITCH BLADDER FIXATION. NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2013 AFTER HER JP DRAIN WAS REMOVED AND SHE WAS ABLE TO URINATE WITHOUT DIFFICULTY. ON (B)(6) 2013, THE PATIENT UNDERWENT A CYSTOSCOPY AND STENT REMOVAL PROCEDURE. DURING THE PROCEDURE, THE PATIENT'S BLADDER WAS DRAINED. NO COMPLICATIONS WERE DOCUMENTED. THE PATIENT CLAIMED THAT SHE WAS TOLD THAT THE URETERAL STRICTURE WAS THE RESULT OF A THERMAL INJURY THAT OCCURRED DURING THE DA VINCI S SUPRACERVICAL HYSTERECTOMY PROCEDURE PERFORMED IN 2010. BASED ON THE PATIENT'S MEDICAL RECORDS, THERE IS NO DOCUMENTATION THAT A THERMAL INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417411 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE