FDA Adverse Event
Injury
Summary report: N
ETHICON ENDO-SURGERY, INC.
MDR report key: 276022
·
Received May 1, 2000
Report
- Report Number
- 276022
- Event Type
- Injury
- Date Received
- May 1, 2000
- Date of Event
- March 25, 2000
- Report Date
- March 30, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ATTEMPTED LAPAROSCOPIC APPENDECTOMY 10 MM TROCAR GUARD FAILED. COMMON ILIAC ARTERY LACERATED. IMMEDIATE LARGE HEMORRHAGE. RAPID INFUSION OF BLOOD AND REPAIR OF LACERATION. PT TO ICU POST-OP. RECOVERING SLOWLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC. | TROCAR | GCJ | ETHICON ENDO-SURGERY, INC. | 511SD | N4GG0E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Hospitalization| L| R |