FDA Adverse Event
Summary report: N
10MM INZII RETRIEVAL SYSTEM 10/BOX
MDR report key: 2112470
·
Received March 22, 2011
Report
- Report Number
- 2027111-2011-00032
- Date Received
- March 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN, FOLLOW UP WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
OOPHERECTOMY - "SURGEON ATTEMPTED TO REMOVE THE RIGHT OVARY THROUGH THE HOLE, THE COVIDIEN 11MM PORT LEFT. SHE HAD DIFFICULTY GETTING THE SPECIMEN OUT AND USED ARMY NAVY RETRACTORS WHILE THE BAG WAS IN THE ABDOMEN. SHE PULLED THE BAG OUT IT TORE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 10MM INZII RETRIEVAL SYSTEM 10/BOX | MONARCH RETRIEVAL BAG | GCJ | APPLIED MEDICAL | CD001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |