FDA Adverse Event
Malfunction
Summary report: N
GDW STAPLE, IMPLANTABLE
MDR report key: 1460551
·
Received May 19, 2009
Report
- Report Number
- 3005075853-2009-02892
- Event Type
- Malfunction
- Date Received
- May 19, 2009
- Date of Event
- April 22, 2009
- Report Date
- April 24, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 05/19/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THERE WAS SOME DIFFICULTY IN CLOSING THE ANVIL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDW STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4LK8T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |