FDA Adverse Event
Injury
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1023319
·
Received April 1, 2008
Report
- Report Number
- 1527736-2008-02039
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- March 13, 2008
- Report Date
- March 13, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING A THIRD DEVICE, A LEAK WAS NOTICED. THE SURGEON CONVERTED TO OPEN AND FIXED THE LEAK WITH NO PATIENT CONSEQUENCE. THE PATIENT IS CURRENTLY DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |