FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE RELOADABLE LINEAR STAPLER
MDR report key: 1160668
·
Received September 5, 2008
Report
- Report Number
- 3005075853-2008-01533
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 13, 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 09/05/2008: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, THE SURGEON FIRED THE DEVICE AND THERE WERE NO STAPLES. THEY SEWED THE BOWEL CLOSED. THERE WAS A SMALL AMOUNT OF BLEEDING, NOTHING SIGNIFICANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4LK60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |