FDA Adverse Event
Malfunction
Summary report: N
45MM ENDO LIN CUTTER/GREEN RLD
MDR report key: 1130169
·
Received August 20, 2008
Report
- Report Number
- 3005075853-2008-01295
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 6, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO AN UNK PROCEDURE, IT WAS FOUND THAT THE PACKAGE HAD BEEN OPENED BEFORE THE DEVICE WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 45MM ENDO LIN CUTTER/GREEN RLD | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |