FDA Adverse Event
Injury
Summary report: N
UNKNOWN ENDO GIA SULU
MDR report key: 2133658
·
Received June 8, 2011
Report
- Report Number
- 1219930-2011-00490
- Event Type
- Injury
- Date Received
- June 8, 2011
- Date of Event
- March 22, 2011
- Report Date
- May 30, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: VATS SEGMENTECTOMY. ACCORDING TO THE REPORTER: THE ROBOT DA VINCI WAS USED. PT TISSUE WAS CHALLENGING. THE TISSUE TORE AND BLED. THE STAPLE LINE WAS NOT COMPLETE. THE SURGEON TRANSFERRED TO OPEN THORAX SURGERY AND ANOTHER DEVICE WAS USED. IN POST OP CONTROL RX A FOREIGN BODY WAS FOUND BETWEEN THE HEART AND THE LUNG. INITIALLY THIS WAS THOUGHT TO BE A CLIP, BUT IT APPEARS TO BE A SMALL PART OF AN INSTRUMENT/DEVICE INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ENDO GIA SULU | DISPOSABLE SURGICAL STAPLING DEVIC | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |