FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1900127
·
Received November 9, 2010
Report
- Report Number
- 1219930-2010-00836
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 3, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE SULU JAMMED ON THE PULMONARY PARENCHYMA TISSUE BEFORE CUTTING OR STAPLING. THE SURGEON COULD NOT RELEASE THE SULU. RESECTION OF PULMONARY TISSUE AND HEMOSTASIS WITH CLIPS TO REMOVE THE INSTRUMENT WERE PERFORMED TO COMPLETE THE OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N0D0790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MFR DATE: 2/2010| ENDO GIA ROTCULATOR 60-3.5 SULU| (B)(4), LOT #: N0B0101, EXP DATE: 2/28/2015 |