FDA Adverse Event
Injury
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1081612
·
Received July 25, 2008
Report
- Report Number
- 3005075853-2008-00672
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- June 25, 2008
- Report Date
- July 23, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE STAPLE LINE OPENED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. HOSPITALIZATION WAS REQUIRED. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4L07W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |