FDA Adverse Event
Malfunction
Summary report: N
PROX ACCESS 55MM ART STAP THIC
MDR report key: 1190777
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02168
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 15, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE FIRED STAPLES THAT WERE MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROX ACCESS 55MM ART STAP THIC | GDW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |