FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1024771
·
Received April 2, 2008
Report
- Report Number
- 1219930-2008-00265
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 19, 2008
- Report Date
- March 24, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAG
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 04/02/2008.
Description of Event or Problem · 1
PROCEDURE: LUNG BIOPSY. ACCORDING TO THE REPORTER: SOME STAPLES (ABOUT 3CM IN LENGTH) WERE NOT FIRED ON ONE SIDE OF THE TISSUE. THERE WAS SOME ADDITIONAL BLEEDING THE AMOUNT OF WHICH IS UNK. THERE WAS NO ADDITIONAL TISSUE LOSS. TISSUE REPAIRED VIA MANUAL SUTURES WITH A CASE DELAY OF ABOUT 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | SURGICAL STAPLING DEVICE | GAG | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | ENDO GIA ROTICULATOR 60-3.5 SULU| 030458 |