FDA Adverse Event
Injury
Summary report: N
GYNECARE MORCELLEX TISSUE MORCELLATOR
MDR report key: 1173373
·
Received September 22, 2008
Report
- Report Number
- 2210968-2008-00839
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 20, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- HET
- PMA / PMN Number
- K061050
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 09/19/2008. BLEEDING OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT ROBOTIC LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY IN 2008. DURING THE PROCEDURE, AS SOON AS THE TROCAR WAS PLACED, A MAJOR VASCULAR INJURY WITH BLEEDING OCCURRED. A VASCULAR SURGEON PERFORMED A MESH PLACEMENT TO REPAIR THE VESSEL AND THE PT WAS SENT TO THE INTENSIVE CARE UNIT. CURRENTLY, THE PT IS DOING BETTER AND IS AT HOME. THE SURGEON OPINES THAT THE DEVICE OBTURATOR IS NOT FLUSH WITH THE SHEATH AND CAUGHT ON THE PATIENT'S SKIN/VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GYNECARE MORCELLEX TISSUE MORCELLATOR | LAPAROSCOPE, GYNECOLOGIC | HET | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |