FDA Adverse Event
Death
Summary report: N
LIGACLIP CLIP APPLIER (EXACT CODE UNKNOWN)
MDR report key: 501131
·
Received December 12, 2003
Report
- Report Number
- 1527736-2003-02630
- Event Type
- Death
- Date Received
- December 12, 2003
- Date of Event
- February 28, 2002
- Report Date
- November 17, 2003
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GDO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
AN UNKNOWN PROCEDURE WAS PERFORMED IN 2002. THE SURGICAL PROCEDURE REQUIRED A LARGE VEIN TO BE CLIPPED AND MOVED. ON ATTEMPTING TO MOVE THE VEIN, THE CLIPS DISLODGED, CAUSING UNCONTROLLED BLEEDING FROM THE VEIN, AND RESULTING IN DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP CLIP APPLIER (EXACT CODE UNKNOWN) | CLIP APPLIERS | GDO | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |