FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-2.5 SULU
MDR report key: 3902284
·
Received June 25, 2014
Report
- Report Number
- 1219930-2014-00477
- Event Type
- Injury
- Date Received
- June 25, 2014
- Date of Event
- April 29, 2014
- Report Date
- June 4, 2025
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: DURING A LUNG LOBECTOMY, THE STAPLING WITH ENDO GIA ULTRA WAS INEFFECTIVE ON THE "PART THAT WAS LEFT" ON THE SIDE OF THE LUNG (LUNG THAT WAS LEFT IN THE PT). THE WHITE SULU (2.5MM) USED DID NOT WORK AND DID NOT COMPLETELY EMPTY OUT, WHICH DID NOT MAKE SUFFICIENT HEMOSTASIS AND AEROSTASIS. MOREOVER, THE HANDLE JAMMED. THE PHYSICIAN HAD TO MAKE A THORACOTOMY AND SUTURE THE SIDE OF THE LUNG THAT WAS LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370580 | ENDO GIA ROTICULATOR 45-2.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL | N2D0284LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other| R | EXP. DATE: 03/31/2018, K083519. | EGIA ULTRA UNIVERSAL STAPLER, EGIAUSTND, | LOT#N3C0314UX, MANUF. DATE: 03/2013,| LOT#N3C0314UX, MANUF. DATE: 03/2013,| EXP. DATE: 03/31/2018, K083519.| EGIA ULTRA UNIVERSAL STAPLER, EGIAUSTND, |