FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL STAPLER
MDR report key: 2250068
·
Received September 9, 2011
Report
- Report Number
- 1219930-2011-00778
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 18, 2011
- Report Date
- September 1, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: VIDEO ASSISTED THORACIC SURGERY. ACCORDING TO THE REPORTER: THE DEVICE FIRED. IT CLAMPED DOWN ON A VESSEL, THEN THE DEVICE COULD NOT BE OPENED. THE SURGEON HAD TO CUT AROUND THE STUCK DEVICE IN ORDER TO REMOVE IT FROM THE TISSUE. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THE CASE WAS DELAYED AROUND 30 MINUTES. NO BLEEDING REPORTED. UNANTICIPATED TISSUE LOSS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGIA ULTRA UNIVERSAL STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N1E0978UKX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | CATALOG # EGIA45AVM, K083519| EGIA 45 ARTICULATING VAS/MED SULU: |