FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR* 60-4.8 SULU
MDR report key: 4220607
·
Received November 3, 2014
Report
- Report Number
- 1219930-2014-00995
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- October 7, 2014
- Report Date
- October 7, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE FIRST RELOAD WAS FIRED ON THE LOWER PART OF THE STOMACH SUCCESSFULLY. WHEN FIRING THE SECOND RELOAD, THE TISSUE WAS PUSHED OUT OF THE STAPLER CARTRIDGE. THE DOCTOR HAS PROVIDED A PICTURE WHICH IS ATTACHED IN THE COMPLAINT FILE. THE DOCTOR USED ANOTHER RELOAD TO RESECT THE AFFECTED TISSUE. THE PATIENT IS FULLY RECOVERED. THERE WAS NO REINFORCEMENT MATERIAL USED. THERE WAS NO EXTENT OF SURGERY TIME BEYOND 30 MINUTES. THERE WAS NO RE-OPERATION NECESSARY. THERE WAS NO BLOOD LOSS OVER 500 CC'S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702530 | ENDO GIA ROTICULATOR* 60-4.8 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 030459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | PRODUCT NUMBER: EGIAUXL |