MORCELLATOR LINA XCISE 15MM LAPSCP 90188 MOR-1515-6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for MORCELLATOR LINA XCISE 15MM LAPSCP 90188 MOR-1515-6 manufactured by Lina Medical Aps.

Event Text Entries

[137676782] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084497
MDR Report Key8378255
Date Received2019-02-27
Date of Report2019-02-18
Date of Event2018-07-10
Date Added to Maude2019-02-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameMORCELLATOR LINA XCISE 15MM LAPSCP
Generic NameLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Product CodeHET
Date Received2019-02-27
Model Number90188
Catalog NumberMOR-1515-6
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerLINA MEDICAL APS
Manufacturer Address1856 CORPORATE DR STE 135 NORCROSS GA 30093 US 30093

Device Sequence Number: 1

Brand NameMORCELLATOR LINA XCISE 15MM LAPSCP
Generic NameTISSUE MORCELLATOR LINA LAPAROSCOPIC GYNECOLOGIC
Product CodeHET
Date Received2019-02-27
Model Number90188
Catalog NumberMOR-1515-6
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerLINA MEDICAL
Manufacturer Address1856 CORPORATE DR STE 135 NORCROSS GA 30093 US 30093


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-27

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