FDA Adverse Event
Injury
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1130478
·
Received August 21, 2008
Report
- Report Number
- 3005075853-2008-01322
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 6, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 DURING A LADG PROCEDURE, AFTER THE FIRING, THE DEVICE COULD NOT BE RELEASED AND ANOTHER DEVICE HAD TO BE USED TO RESECT THE SITE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4LC1R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |