FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT - THICK
MDR report key: 1081886
·
Received July 22, 2008
Report
- Report Number
- 3005075853-2008-00625
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- April 10, 2008
- Report Date
- June 30, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 7/22/08. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, THE DEVICE CUT BUT PARTIALLY STAPLED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT - THICK | GDW | ETHICON ENDO-SURGERY, LLC | NA | D45J42 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |