FDA Adverse Event
Injury
Summary report: N
KARL STORZ MORCELLATOR
MDR report key: 4156036
·
Received October 1, 2014
Report
- Report Number
- 9610617-2014-00046
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- February 21, 2011
- Report Date
- September 15, 2014
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- GCJ
- PMA / PMN Number
- K061180
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO INDICATION IN THE SUMMONS WHICH MANUFACTURES' MORCELLATOR WAS USED, OR ANY MALFUNCTION OF THE DEVICE.
Description of Event or Problem · 1
ALLEGEDLY, PER A SUMMONS, RECEIVED BY KARL STORZ ENDOSCOPY-AMERICA, INC., THE PLAINTIFF'S DECEASED SISTER UNDERWENT A ROBOT-ASSISTED PROCEDURE AT (B)(6) WHERE A MORCELLATOR WAS USED. THE PROCEDURE CAUSED DISSEMINATION OF CANCER, SHE SUFFERED AND DIED FROM, WHICH WAS DIAGNOSED FIVE MONTHS LATER AT THE TIME OF HER SECOND LAPAROTOMY IN (B)(6) 2011. BOTH (B)(4) AND KARL STORZ WERE NAMED IN THE LAWSUIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610114 | KARL STORZ MORCELLATOR | MORCELLATOR | GCJ | KARL STORZ GMBH & CO. KG | 26713030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |