FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1032858
·
Received April 22, 2008
Report
- Report Number
- 1219930-2008-00318
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- April 17, 2008
- Report Date
- April 21, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAG
- PMA / PMN Number
- K061095
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 04/22/2008.
Description of Event or Problem · 1
FIRST FIRING WAS SUCCESSFUL. HOWEVER, ON THE SECOND FIRING, THE KNIFE BLADE WOULD ADVANCE BUT STAPLES WOULD NOT FORM PROPERLY, STAYED THEIR LEGS STRAIGHT. OVER 200CC/UNDER 500CC BLEEDING OCCURRED. THE INCOMPLETE STAPLE LINE WAS CLOSED BY MANUAL SUTURING, AND THEN FIRED WITH ECHELON, THE COMPETITOR'S STAPLER. PATIENT: UNDER OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | NONE | GAG | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT # UNK| EXPIRATION - UNK| 030459 |