FDA Adverse Event
Death
Summary report: N
GIA UNIVERSAL
MDR report key: 2042196
·
Received March 29, 2011
Report
- Report Number
- 1219930-2011-00172
- Event Type
- Death
- Date Received
- March 29, 2011
- Date of Event
- January 28, 2011
- Report Date
- March 3, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: PNEUMONECTOMY. ACCORDING TO THE RPTR: THIS WAS A RIGHT PNEUMONECTOMY INSIDE THE PERICARDIUM TO RESECT A VOLUMINOUS CANCER OVERLAPPING THE SUPERIOR VENA CAVA WITH SECTION OF THE VENA CAVA AND WIDE OPENING OF THE PERICARDIUM. THE STAPLING WAS DONE OVER THE ENTIRE WIDTH OF THE PULMONARY ARTERY, THE VENA CAVA, AND THE AORTA. THE INSTRUMENTS DID NOT STAPLE THE COMPLETE LINE. THEN THE TRANSECTION OPENED AS THE STAPLES DID NOT STAY CLOSED. THERE WAS MASSIVE HEMORRHAGE AND HEART FAILURE. HEMODYNAMIC REANIMATION UNSUCCESSFUL. THE PT EXPIRED. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | ENDO GIA ROTICULATOR 30-2.5 SULU, (B)(4)| LOT NUMBER: N0C0534, EXP DATE: 03/31/2015,| MANUFACTURE DATE: 03/2010 |