FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-2.0 SULU
MDR report key: 3170119
·
Received June 6, 2013
Report
- Report Number
- 1219930-2013-00429
- Event Type
- Injury
- Date Received
- June 6, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 16, 2013
- Manufacturer
- CO IDIEN, FORMERLY US SUR
- Product Code
- GAG
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: VATS/RIGHT LOWER LOBECTOMY. ACCORDING TO THE REPORTER: ROTICULATOR 45-3.5 SULU WAS USED TO FORM INTERLOBAR AND ROTICULATOR 45-2.5 SULU WAS USED TO CUT THE PULMONARY ARTERY. AFTER 3RD FIRING ON THE INFERIOR PULMONARY VEIN WITH ROTICULATOR 40-2.0 SULU, BLOOD SPURTED FROM AROUND THE CENTER OF THE STUMP. THE SMALL INCISION WAS EXTENDED BY ABOUT 3 CM, AND THE BLEEDING SITE WAS GRASPED WITH THE FORCEPS AND WAS CAREFULLY SUTURED. BLEEDING STOPPED BEFORE IT BECAME SERIOUS. AMOUNT OF BLEEDING: ABOUT 300 CC. THERE WAS TISSUE DAMAGE. NO UNANTICIPATED TISSUE LOSS, NOTHING FELL INTO CAVITY, THE PT IS RECOVERING. OPERATING TIME WAS EXTENDED BY MORE THAN 2 HOURS. NO INFORMATION ABOUT THE USE OF REINFORCEMENT MATERIAL WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251946 | ENDO GIA ROTICULATOR 45-2.0 SULU | DISPSOABLE SURGICAL STAPLER | GAG | CO IDIEN, FORMERLY US SUR | N2K0401LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | GIA UNIVERSAL, 030403, LOT NUMBER: N2J0409X| EXP DATE: 09/30/2017, MANUF DATE: 09/01/2012 |