FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-4.8 SULU
MDR report key: 1180106
·
Received September 29, 2008
Report
- Report Number
- 1219930-2008-00708
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 24, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 09/29/2008.
Description of Event or Problem · 1
PROCEDURE: LUNG RESECTION. ACCORDING TO THE REPORTER: THE HANDLE LOCKED UP AT HALFWAY THROUGH THE 4TH FIRING AND THE JAWS WOULD NOT OPEN. THE INSTRUMENT WAS RESECTED WITH NEW STAPLER AND SULU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-4.8 SULU | DISPOSABLE STAPLING DEVICE | GDW | NORTH HAVEN - USS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 030449| ENDO GIA UNIVERSAL 12MM SINGLE USE INST |