MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-03 for LINA POWER MORCELLATOR MOR-1515-6 manufactured by Lina Medical Aps.
[140782725]
Based on description placed in mw5084497 we can conduct that incident wasn't connected with device malfunction. Furthermore device information is not sufficient to review dhr documentation (batch number is unknown). No further action required. [mw5084497 provided by fda].
Patient Sequence No: 1, Text Type: N, H10
[140782726]
Above description was copied from mw5083832 report provided to lina by mr (b)(6) from department of heath &human services. Lina medical aps haven't been aware about such event. "a (b)(6) female admitted on 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 well as an intramural lower uterine segment fibroid anteriorly on the right side. No evidence of endometriosis. No evidence of adhesions. Fallopian was morcellated (patient had gone through selection criteria in order to use power morcellation) with specimen sent to pathology for evaluation. Th endoscopic bag caught all small fibroid fragments well as fluid. Pathology: fragments of leiomyoma. See again in office on (b)(6) 218 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 7cm, 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 form the mesentery of the large bowel (located in the lower abdomen at the pelvic brim), appendix was wrapped around the mass as well. Multiple miomas 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 15,8x11,7x13,74 cm central abdominopelvic, several additional peritoneal/mesenteric masses seen with second largest measuring 4,7x3,6 cm, mild prominence/nodularity along l. Vaginal cuff, low density lesion 3,4x1,9cm adjacent to the porta hepatis in the liver possible focal fat, stable periportal ln 2,2x1,4 cm. Not a surgical candidate given the central mesenteric involvement of her lesions. " all information filled in the next steps are also copy from mw5083832 report. Information are not sufficient to conduct what product it was exactly (lack batch number).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007699067-2019-00002 |
| MDR Report Key | 8477476 |
| Report Source | OTHER |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MONIKA LEWANDOWSKA |
| Manufacturer Street | FORMENVANGEN 5 |
| Manufacturer City | GLOSTRUP, DENMARK DK2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK2600 |
| Manufacturer G1 | LINA MEDICAL POLSKA SP Z O.O. |
| Manufacturer Street | ROLNA 8A SADY |
| Manufacturer City | TARNOWO PODG 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA POWER MORCELLATOR |
| Generic Name | LINA MORCELLATOR |
| Product Code | HET |
| Date Received | 2019-04-03 |
| Catalog Number | MOR-1515-6 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 DENMARK GLOSTRUP, DK2600 DA DK2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-03 |