FDA Adverse Event
Injury
Summary report: N
EGIA 45 ARTICULATING VAS/MED SULU
MDR report key: 2831005
·
Received November 2, 2012
Report
- Report Number
- 1219930-2012-00864
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 12, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GDW
- PMA / PMN Number
- K101444
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: THE FIRST RELOAD ON THE ENDO GIA STAPLER JAMMED AND WOULD NOT RELEASE FROM THE RESECTED AREA. THE SURGEON LIGATED THE PULMONARY VEIN WITH SUTURE AND REMOVED THE STAPLED SUTURE LINE/RELOAD. PROLONGATION OF SURGERY TIME BY MORE THAN 30 MIN. FULL RECOVERY OF PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGIA 45 ARTICULATING VAS/MED SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SUR | N2B0167ULX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | GIA* UNIVERSAL: 030403, LOT# N1L0193X| MFG: 11/2011, EXP: 11/30/2016, K061095 |