FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 314076
·
Received January 25, 2001
Report
- Report Number
- 1527736-2001-00295
- Event Type
- Malfunction
- Date Received
- January 25, 2001
- Date of Event
- November 6, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
AN EXTERNAL MEDWATCH FORM NUMBER 06-0009-2000-016 WAS RECEIVED, "ETHICON PROFINATE 55 ARTICULATING LINEAR STAPLER MISFIRED. MULTIPLE STAPLES CAME OUT IN ONE PARTICULAR PLACE IN COLON RESECTION. THE SURGEON THEN OVERSEWED THE BOWEL TO COMPLETE THE CASE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3217 | * | LINEAR STAPLERS | GAG | ETHICON ENDO-SURGERY, INC. | NA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |