BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5084497

    MDR report key: 8378255 · Received February 27, 2019

    Report

    Report Number
    MW5084497
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    July 10, 2018
    Report Date
    February 18, 2019
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED ON (B)(6) 2017 FOR ROBOTIC-ASSISTED LAPAROSCOPIC MULTIPLE MYOMECTOMIES. PATIENT HAD EXTREMELY LARGE FIBROID UTERUS WITH 2 VERY LARGE FIBROIDS IN THE FUNDAL REGION OF THE UTERUS MORE POSTERIORLY. THERE WERE SEVERAL SUBCENTIMETER FIBROIDS THAT WERE SUBSEROSAL AS WELL AS AN INTRAMURAL LOWER UTERINE SEGMENT FIBROID ANTERIORLY ON THE RIGHT SIDE. NO EVIDENCE OF ENDOMETRIOSIS. NO EVIDENCE OF ADHESIONS. FALLOPIAN TUBES AND OVARIES APPEARED NORMAL. RIGHT UPPER QUADRANT WAS NORMAL WITH A FATTY APPEARING LIVER. MASS WAS THEN PLACED INTO THE BAG. THE FIBROID WAS MORCELLATED (PATIENT HAD GONE THROUGH SELECTION CRITERIA IN ORDER TO USE POWER MORCELLATION) WITH SPECIMEN SENT TO PATHOLOGY FOR EVALUATION. THE ENDOSCOPIC BAG CAUGHT ALL SMALL FIBROID FRAGMENTS WELL AS FLUID. PATHOLOGY: FRAGMENTS OF LEIOMYOMA. SEE AGAIN IN OFFICE ON (B)(6) 2018 FOR REOCCURRENCE OF FIBROIDS. HAS CHRONIC PELVIC AND ABDOMINAL PAIN, WORSENED IN (B)(6) 2018 EVALUATED BY PCP, SENT FOR U/S AND CT, WHICH SHOWED 4 FIBROIDS, THE LARGEST MEASURING 7 CM, DESIRES DEFINITIVE TREATMENT. CONSENT FOR ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, MYOMECTOMY, LYSIS OF ADHESIONS, NECROLYSIS AND CYSTOSCOPY (DOS- (B)(6) 2018). FINDINGS: MULTIPLE FIBROIDS WITHIN THE UTERUS ITSELF, A LARGE 10 CM MASS CONSISTENT WITH A UTERINE FIBROID THAT WAS SEPARATE FROM THE UTERUS AND GROWING FROM THE MESENTERY OF THE LARGE BOWEL (LOCATED IN THE LOWER ABDOMEN AT THE PELVIC BRIM), APPENDIX WAS WRAPPED AROUND THE MASS AS WELL. MULTIPLE MYOMAS SCATTERED THROUGH THE PELVIS, NOT PART OF THE UTERUS, SEVERAL INVOLVING THE SMALL AND LARGE BOWEL. PATHOLOGY: UTERUS, CERVIX, LEFT TUBE LEIOMYOSARCOMA (HIGH GRADE). SEEN AT (B)(6). CT SCAN COMPLETED ON (B)(6) 2018, JUST 3 WEEKS AFTER HER SURGERY, 0.2 CM RML PULMONARY NODULE, MILDLY ENLARGED R PARATRACHEAL LN W/SEVERAL ADDITIONAL MEDIASTINAL LNS LESS THAN 1 CM, INCREASE SIZE AND NUMBER OF PERITONEAL AND MESENTERIC MASSES THE LARGEST NOW MEASURE 15.8X11.7 X 13.74 CM CENTRAL ABDOMINOPELVIC, SEVERAL ADDITIONAL PERITONEAL/MESENTERIC MASSES SEEN WITH SECOND LARGEST MEASURING 4.7 X 3.6 CM, MILD PROMINENCE/NODULARITY ALONG L. VAGINAL CUFF, LOW DENSITY LESION 3.4 X 1.9 CM ADJACENT TO THE PORTA HEPATIS IN THE LIVER POSSIBLE FOCAL FAT, STABLE PERIPORTAL LN 2.2 X 1.4 CM. NOT A SURGICAL CANDIDATE GIVEN THE CENTRAL MESENTERIC INVOLVEMENT OF HER LESIONS.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other