FDA Adverse Event
Malfunction
Summary report: N
ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM
MDR report key: 1160693
·
Received September 5, 2008
Report
- Report Number
- 3005075853-2008-01558
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 29, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE WOULD CUT BUT IT STAPLED PARTIALLY. THE DEVICE WORKED PROPERLY WITH FOUR RELOADS, AT THE FIFTH RELOAD IT BLOCKED THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM | GDW | ETHICON ENDO-SURGERY, LLC. | NA | E4LA0U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |