FDA Adverse Event
Other
Summary report: N
ARTICULATOR 35
MDR report key: 277842
·
Received May 10, 2000
Report
- Report Number
- 1824347-2000-00013
- Event Type
- Other
- Date Received
- May 10, 2000
- Report Date
- April 12, 2000
- Manufacturer
- IMAGYN SURGICAL
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ARTICULATOR 35 WAS BEING USED TO DIVIDE AND LIGATE. STAPLE LINES BLED THROUGH, VESSELS WERE IGATED WITH SURGICAL TIES.
Description of Event or Problem · 1
ARTICULATOR 35 WAS BEING USED TO DIVIDE AND LIGATE. STAPLE LINES BLED THROUGH. VESSELS WERE LIGATED WITH SURGICAL TIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTICULATOR 35 | ARTICULATOR 35 | GAG | IMAGYN SURGICAL | 4325 | 13C00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other | ||
| 2 |