FDA Adverse Event
Injury
Summary report: N
ENDO GIA II 45-3.5 DLU
MDR report key: 1820718
·
Received August 27, 2010
Report
- Report Number
- 2647580-2010-00732
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- March 8, 2010
- Report Date
- August 16, 2010
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE SURGEON STARTED TO FIRE, CUT TISSUE AND THEN THE JAWS LOCKED ON TISSUE. THE BLACK RETURN KNOB LOCKED AND BROKE DURING FIRING. THE SURGEON USED TWEEZERS TO OPEN THE JAWS AND TO REMOVE THE SULU. THE EVENT RESULT IN UNANTICIPATED TISSUE LOSS, WITH DAMAGE OF THE TISSUE DURING THE TISSUE REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA II 45-3.5 DLU | DISPOSABLE STAPLER | GDW | USSC PUERTO RICO | P9K0255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |