FDA Adverse Event
Malfunction
Summary report: N
ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM
MDR report key: 1831689
·
Received September 12, 2007
Report
- Report Number
- 1527736-2007-06013
- Event Type
- Malfunction
- Date Received
- September 12, 2007
- Date of Event
- August 28, 2007
- Report Date
- August 29, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE STAPLES WERE UNFORMED. ADDITIONAL SUTURE WAS PERFORMED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | D4HK2G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |