FDA Adverse Event
Other
Summary report: N
12X130MM KII BALLOON TROCAR
MDR report key: 1593823
·
Received February 1, 2010
Report
- Report Number
- 2027111-2010-00012
- Event Type
- Other
- Date Received
- February 1, 2010
- Date of Event
- December 18, 2009
- Report Date
- January 28, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AND EVAL OF THE INCIDENT DEVICE, A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
"THE C0R37 WAS UTILIZED AS A CAMERA PORT FOR A 10MM ROD LENS SCOPE. ABOUT 20 MINUTES INTO THE PROCEDURE, THE DR. NOTICED PLASTIC SHARD IN PT'S ABDOMEN. CONTINUED TO FLAKE OR BREAK AT DISTAL TIP. PLEASE EXPLAIN".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X130MM KII BALLOON TROCAR | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0R50 | 1101748 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |