FDA Adverse Event
Other
Summary report: N
10MM INZII RETRIEVAL SYSTEM 10/BOX
MDR report key: 1943806
·
Received December 20, 2010
Report
- Report Number
- 2027111-2010-00121
- Event Type
- Other
- Date Received
- December 20, 2010
- Date of Event
- October 14, 2010
- Report Date
- December 20, 2010
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS UNDER ENGINEERING EVAL. WILL SEND F/U WITHIN 30 DAYS.
Description of Event or Problem · 1
INCIDENT AS REPORTED: LAPAROSCOPY (GALL BLADDER) - "GALL BLADDER IN POUCH. SURGEON BROUGHT BAG THROUGH PORT. USED NORMAL PRESSURE AND BAG BROKE APART. OPERATING ROOM NURSE THOUGHT, A PIECE CAME OFF THE BAG AND FELL BACK IN THE PT. DOCTOR AND NURSE USED THE LAPAROSCOPE TO SEE INSIDE AND FOUND A PIECE PLASTIC STUCK IN PORT SITE INSIDE BELLY OF WOUND. POSSIBLY USED A GRASPER TO RETRIEVE THE DEVICE. PT IS FINE. NO OTHER ACTION EXPECTED."
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 | 1120082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |