FDA Adverse Event
Death
Summary report: N
UNIDRIVE GYN MORCELLATOR SYSTEM
MDR report key: 5420506
·
Received February 9, 2016
Report
- Report Number
- 9610617-2016-00008
- Event Type
- Death
- Date Received
- February 9, 2016
- Date of Event
- September 20, 2013
- Report Date
- February 8, 2016
- Manufacturer
- KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
- Product Code
- GCJ
- PMA / PMN Number
- K061180
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE. NOT RETURNED BY HOSPITAL.
Description of Event or Problem · 1
ALLEGEDLY, THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPY SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR UTERINE FIBROIDS ON (B)(6) 2012 IN WHICH A MORCELLATOR WAS USED. ON (B)(6) 2012 LEIOMYOSARCOMA WAS DIAGNOSED SHORTLY AFTER THE SURGERY BASED UPON THE PATHOLOGICAL ANALYSIS. SHE DIED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76813 | UNIDRIVE GYN MORCELLATOR SYSTEM | MORCELLATOR MOTOR SYSTEM | GCJ | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY | 26711101-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |