FDA Adverse Event
Summary report: N
12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR
MDR report key: 2832072
·
Received October 26, 2012
Report
- Report Number
- 2027111-2012-00322
- Date Received
- October 26, 2012
- Date of Event
- October 5, 2012
- Report Date
- October 26, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- LZN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOT # TO BE CONFIRMED UPON RETURNING PRODUCT FROM THE HOSPITAL. THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAPAROSCOPY FOR ECTOPIC PRES: "ON INSERTION OF TROCAR, SURGEON PERFORATED RIGHT ILEAC ARTERY AND PERFORATED THE BOWEL AND THE TROCAR WENT THROUGH TO THE SPINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR | NONE | LZN | APPLIED MEDICAL | CTB73 | TBD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |