FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-3.5 SULU
MDR report key: 1032074
·
Received April 21, 2008
Report
- Report Number
- 1219930-2008-00311
- Event Type
- Injury
- Date Received
- April 21, 2008
- Date of Event
- April 16, 2008
- Report Date
- April 17, 2008
- Manufacturer
- NORTH HAVEN - USS
- 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
INITIAL REPORT SENT TO FDA ON 04/21/2008.
Description of Event or Problem · 1
PROCEDURE: LUNG RESECTION. ACCORDING TO THE REPORTER: ON THE SECOND AND THIRD FIRINGS STAPLES DID NOT FORM PROPERLY. ALTHOUGH FIRINGS WERE DONE COMPLETELY, TISSUE WAS NOT CUT COMPLETELY. OOZING OCCURRED. INCISION WAS EXTENDED 7 - 8 CM AND TISSUE WAS RESECTED AND SUTURED MANUALLY. BOTH CARTRIDGES WERE FIRED IN ARTICULATED POSITION. PATIENT: UNDER OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 45-3.5 SULU | NONE | GAG | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |