FDA Adverse Event
Injury
Summary report: N
GIA 60-3.8 SINGLE USE RELOADABLE STAPLER
MDR report key: 2150481
·
Received June 16, 2011
Report
- Report Number
- 2647580-2011-00422
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 16, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE KNOB WOULD NOT REACH THE TIP OF THE DEVICE. THE RESECTION WAS FULLY DONE. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE DAMAGE WAS REPORTED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA 60-3.8 SINGLE USE RELOADABLE STAPLER | DISPOSABLE SURGICAL ACCESS DEVICE | GDW | USSC PUERTO RICO | P1C0183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |