FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-4.8 SULU
MDR report key: 1030049
·
Received April 15, 2008
Report
- Report Number
- 1219930-2008-00289
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- March 18, 2008
- Report Date
- April 6, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- 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 04/15/2008.
Description of Event or Problem · 1
PROCEDURE: LUNG RESECTION. ACCORDING TO THE REPORTER: THE CLAMP COVER DISENGAGED AND STAPLES DID NOT FORM PROPERLY. THE SURGEON RETRIEVED THEM FROM THE CAVITY AND FIRED WITH ANOTHER LOADING UNIT BUT THE SAME THING OCCURRED. THERE WAS BLEEDING BUT THE VOLUME WAS NOT KNOWN. A DIFFERENT SIZE LOADING UNIT WAS NOT KNOWN. A DIFFERENT SIZE LOADING UNIT WAS SUBSEQUENTLY APPLIED AND WAS OVERSEWED. SURGERY TIME WAS INCREASED BY APPROXIMATELY 30 MINUTES. PT STATUS REPORTED AS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-4.8 SULU | SURGICAL STAPLING DEVICE | GDW | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |