FDA Adverse Event
Injury
Summary report: N
5MM X 32CM, A-TRAC LAPAROSCOPIC GRASPER
MDR report key: 360237
·
Received November 14, 2001
Report
- Report Number
- 2027111-2001-00035
- Event Type
- Injury
- Date Received
- November 14, 2001
- Report Date
- November 13, 2001
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE JAWS OF THE GRASPER OUT OF ALIGNMENT AND AS A RESULT THE DOCTOR DAMAGED A FALLOPIAN TUBE. CAUTERY ON THE FALLOPIAN TUBE WAS USED AS MEDICAL INTERVENTION. IN FOLLOWING UP, THERE WAS NO PERMANENT INJURY OR PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51473 | 5MM X 32CM, A-TRAC LAPAROSCOPIC GRASPER | A-TRAC GRASPER | GCF | APPLIED MEDICAL RESOURCES | C5208 | EOM028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |