FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1024772
·
Received April 2, 2008
Report
- Report Number
- 1219930-2008-00266
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 27, 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 04/02/2008.
Description of Event or Problem · 1
PROCEDURE: LUNG BIOPSY. ACCORDING TO THE REPORTER: ON THE FIRST FIRING, STAPLES DID NOT FORM PROPERLY, REPORTED AS FORMED WITH STRAIGHT LEGS. THERE WAS BLEEDING BUT THE AMOUNT IS UNK, THERE WAS NO ADDITIONAL TISSUE LOSS. THE POOR STAPLE LINE WAS FIXED WITH SUTURE WAS DELAYED THE CASE 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 | 030458| ENDO GIA ROTICULATOR 60-3.5 SULU |