BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3140322 · Received May 31, 2013

    Report

    Report Number
    2955842-2013-01945
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCS INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IT IS UNKNOWN IF THE MCS INSTRUMENT HAS BEEN USED IN ANY SUBSEQUENT SURGICAL PROCEDURES AFTER THE REPORTED EVENT OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION). ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. ON (B)(6) 2013, THE SITE PROVIDED ISI WITH A COPY OF THEIR UF IMPORTER (B)(4). THE UF IMPORTER REPORT INDICATED THAT THE PATIENT UNDERWENT A ROBOTICALLY ASSISTED TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2012 AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013 THE PATIENT ARRIVED AT THE HOSPITAL'S EMERGENCY DEPARTMENT WITH COMPLAINTS OF ABDOMINAL PAIN, BACK PAIN AND NAUSEA AND VOMITING. A CT SCAN PERFORMED ON THE PATIENT'S ABDOMEN WAS INCONCLUSIVE FOR SMALL BOWEL OBSTRUCTION OR ILEUS. THE PATIENT WAS THEN ADMITTED INTO THE HOSPITAL FOR EVALUATION. AN EXPLORATORY LAPAROTOMY, BOWEL RESECTION AND DIVERTING COLOSTOMY WERE PERFORMED ON THE PATIENT. A THERMAL BURN TO THE PATIENT'S RECTUM WAS DISCOVERED DURING A POST-SURGICAL DIAGNOSIS. THE MCS INSTRUMENT WAS USED DURING THE SURGICAL PROCEDURE. AS OF (B)(4) 2013, NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HAS BEEN PROVIDED BY THE SITE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED COPIES OF THE PATIENT'S OPERATIVE REPORTS (OP). THE OP REPORT FOR THE SURGERY DATE OF (B)(6) 2013 INDICATES THAT THE PATIENT UNDERWENT A VINCI HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS UTERINE LEIOMYOMA, MENORRHAGIA THAT WAS UNRESPONSIVE TO MEDICAL THERAPY. DURING EXAMINATION OF THE PATIENT UNDER ANESTHESIA, IT WAS NOTED THAT THE PATIENT'S UTERUS WAS APPROXIMATELY 11-12 WEEKS IN SIZE AND THE PATIENT'S UTERINE CAVITY SOUNDED TO 10CM. UNDER LAPAROSCOPY IT WAS DISCOVERED THAT THE PATIENT'S PELVIS WAS NORMAL, WITH SOME ADHESIONS BETWEEN THE RECTUM AND THE POSTERIOR CERVIX. THE PATIENT'S TUBES AND OVARIES WERE NOTED TO BE NORMAL BILATERALLY. THERE WERE NO COMPLICATIONS. BASED ON THE INFORMATION AS INDICATED IN THE PATIENT'S OP REPORT, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED, EXCELLENT HEMOSTASIS WAS NOTED. THE PATIENT'S ABDOMEN WAS IRRIGATED AND APPEARED HEMOSTATIC. ALL OF THE PATIENT'S PEDICLES WERE INSPECTED AND APPEARED HEMOSTATIC. THE OP REPORT ALLEGES THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND THAT THE PATIENT WAS MOVED TO THE RECOVERY ROOM IN STABLE CONDITION. A SECOND OP REPORT RECEIVED BY ISI INDICATES THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS SUBSEQUENTLY RE-ADMITTED INTO THE HOSPITAL'S EMERGENCY ROOM PRESENTING SYMPTOMS OF EXCRUCIATING ABDOMINAL PAIN. THE PATIENT WAS UNABLE TO TOLERATE DIET AND HAD NO BOWEL FUNCTION. EVALUATION OF THE PATIENT FOUND THAT SHE WAS INCREASINGLY TACHYCARDIAC AND HAD NO PRIOR HISTORY OF BEING ON BETA BLOCKER. THE PATIENT HAD HIGH FEVERS, ELEVATED WHITE BLOOD COUNT AND DURING EXAMINATION, THE PATIENT'S ABDOMEN WAS NOTED TO BE DISTENDED WITH SIGNIFICANT GENERALIZED TENDERNESS WITH INCREASED TENDERNESS AT THE SUPRAPUBIC SITE WITH GUARDING AND REBOUND. DURING A CT SCAN PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT HAD DILATED LOOPS OF BOWEL, NONSPECIFIC, WITH NO TRANSITION POINT, AND ALSO SOFT TISSUE INDURATION IN THE PELVIS WITH A SMALL AMOUNT OF PELVIC FLUID. DURING AN EXPLORATORY LAPAROTOMY IT DISCOVERED THAT THE PATIENT HAD DILATED LOOPS OF BOWEL FROM THE LIGAMENT OF TREITZ TO THE TERMINAL ILEUM, INCLUDING THE CECUM, ASCENDING COLON, ALL THE WAY DOWN TO THE DESCENDING COLON. THE BOWEL WAS GROSSLY DISTENDED WITH NO ADHESIONS AND NO SIGN OF MECHANICAL OBSTRUCTION. EXAMINATION OF THE PATIENT'S SMALL BOWEL FOUND NO INJURY OR MECHANICAL OBSTRUCTION, AND NO SIGNS OF PERFORATION. THE CECUM, ASCENDING COLON, HEPATIC FLEXURE, TRANSVERSE COLON, SPLENIC FLEXURE AND DESCENDING COLON WERE ALSO EXAMINED AND ASIDE FROM THE DISTENTION OF THE LARGE BOWEL, THERE WAS NO SIGNIFICANT OBSTRUCTION, INJURY OR PERFORATION NOTED. THE SIGMOID WAS NOTED TO BE REDUNDANT AND APPEARED TO BE IN THE PELVIS. A SIGNIFICANT AMOUNT OF DARK TISSUE WAS NOTED AT THE ANTERIOR RECTUM AND RECTOSIGMOID JUNCTION. THE ANTERIOR RECTUM WAS SEVERELY INFLAMED WITH WHAT APPEARED TO BE SIGNIFICANT THERMAL INJURY OF THE RECTUM. THE MESENTERY OF THE RECTOSIGMOID WAS NOTED TO BE EDEMATOUS WITH AIR TRACKING INTO THE MESENTERY OF THE RECTOSIGMOID. A SIGMOID RESECTION AND COLOSTOMY AND A HARTMANN POUCH PROCEDURE WERE PERFORMED TO REPAIR THE DAMAGE TO THE PATIENT'S RECTUM. PER THE INFORMATION INDICATED IN THE OP REPORT, AFTER COMPLETION OF THE SURGICAL PROCEDURE THE PATIENT'S ABDOMEN WAS COPIOUSLY IRRIGATED SEVERAL TIMES. ADEQUATE HEMOSTASIS WAS OBTAINED. THE PATIENT'S SMALL BOWEL WAS RE-EVALUATED FROM THE LIGAMENT OF TREITZ AT THE TERMINAL ILEUM, THE CECUM, ASCENDING COLON, HEPATIC FLEXURE, TRANSVERSE COLON AND ALL THE WAY TO THE DESCENDING COLON. THERE WAS NO ADDITIONAL PATHOLOGY NOTED. THE SURGEON NOTED THAT THE PROXIMAL DESCENDING COLON REACHED EASILY TO THE PROPOSED COLOSTOMY SITE WITHOUT TENSION AND A DISK OF SKIN WAS REMOVED FROM THE COLOSTOMY OF THE ABDOMINAL WALL AND WAS DILATED TO ADMIT 3 FINGERS. THE COLON WAS PASSED THROUGH THE OSTOMY SITE WITH NO TORSION OR TENSION AND THE PATIENT'S ABDOMEN WAS COPIOUSLY IRRIGATED WITH EXCELLENT HEMOSTASIS OBTAINED. AN OSTOMY BAG WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT'S HEART RATE WAS NOTED TO BE IN THE 80S. THE PATIENT WAS TAKEN TO THE POST-OPERATIVE CARE UNIT IN STABLE CONDITION FOR ADDITIONAL POST-OPERATIVE MANAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL THE FOLLOWING WEEK DUE TO EXPERIENCING PAIN. DURING A SURGICAL EXAMINATION PERFORMED ON THE PATIENT IT WAS DISCOVERED THAT THE PATIENT'S RECTUM WAS NECROTIC AND HAD POSSIBLE CAUTERIZED TISSUE. THE PATIENT UNDERWENT A REVERSIBLE COLOSTOMY PROCEDURE. REPORTEDLY, NO SYSTEM ISSUES OR PATIENT INJURY WAS OBSERVED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL SUMMONS INDICATING THAT THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 AND POST OPERATIVELY THE PATIENT EXPERIENCED COMPLICATIONS RELATED TO INTRA-ABDOMINAL BLEEDING, THERMAL BURNING, SEVERE, INFECTION WITH INTRAABDOMINAL ABSCESSES AND OTHER MEDICAL COMPLICATIONS, WHICH REQUIRED THE PATIENT TO UNDERGO IMMEDIATE FURTHER SURGERY ON (B)(6) 2013. THE LEGAL SUMMONS ALLEGES THAT THE PATIENT CONTINUES TO SUFFER FROM CHRONIC ABDOMINAL PAIN, SEVERE BOWEL ISSUES AND OTHER ISSUES. THE LEGAL SUMMONS ALLEGES THAT DUE TO THE PATIENT'S INJURIES, SHE HAS HAD TO UNDERGO MULTIPLE PAINFUL ADDITIONAL MEDICAL TESTS, PROCEDURES AND PHYSICIAN CONSULTATIONS. REPORTEDLY, THE PATIENT HAS UNDERGONE ADDITIONAL SURGERY AND HAS SUFFERED PAIN, LOSS OF FUNCTION EMOTIONAL DISTRESS AND PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241750 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10130304 867

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention DAV SI SURG. SYS., INSTMNTS, TIP CVR ACCESS & ESU