FDA Adverse Event
Injury
Summary report: N
GIA UNIVERSAL
MDR report key: 1100888
·
Received August 6, 2008
Report
- Report Number
- 1219930-2008-00586
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 30, 2008
- Report Date
- August 1, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 08/06/2008.
Description of Event or Problem · 1
PROCEDURE: LOW ANTERIOR RESECTION DOUBLE STAPLE. ACCORDING TO THE REPORTER: WHEN FIRED ACROSS RECTUM, THE INSTRUMENT MADE A CRACKING NOISE AND PRODUCED NO STAPLES. THE CARTRIDGE WAS RELEASED FROM TISSUE WITH NO DAMAGE BUT COULD NOT BE REMOVED FROM THE STAPLER. THE SURGEON RESECTED TISSUE AND SUTURED MANUALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE STAPLING DEVICE | GDW | NORTH HAVEN - USS | N8E92 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Disability |