FDA Adverse Event
Injury
Summary report: N
ETHICON ENDO-SURGERY, INC.
MDR report key: 284122
·
Received June 30, 2000
Report
- Report Number
- 284122
- Event Type
- Injury
- Date Received
- June 30, 2000
- Date of Event
- May 19, 2000
- Report Date
- May 25, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT UNDERWENT DIAGNOSTIC LAPAROSCOPY. AT CONCLUSION OF PROCEDURE PT BECAME TACHYCARDIC, HYPOXIC, WITH ABDOMINAL DISTENTION. EMERGENT LAPAROTOMY DONE WITH REPAIR OF ILIAC ARTERY AT BIFURCATION OF AORTA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC. | BLUNT TIP TROCAR WITH RADIOLUCENT SLEEVE | GCJ | ETHICON ENDO-SURGERY, INC. | 512B | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Hospitalization| L| R |