FDA Adverse Event
Injury
Summary report: N
ECHELON 45 ENDOPATH STAPLER
MDR report key: 1241097
·
Received November 21, 2008
Report
- Report Number
- 3005075853-2008-03272
- Event Type
- Injury
- Date Received
- November 21, 2008
- Report Date
- November 19, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE DEVICE WAS USED WITH A BLUE LOAD AND THE STAPLE LINE LOOKED GOOD. THE SURGEON CHECKED FOR LEAKS AND NONE WERE FOUND. POST OP, THE DRAIN WAS SHOWING BLOOD. THE SURGEON PERFORMED AN OPERATIVE LAPAROSCOPY WHERE HE FOUND AN ARTERIAL BLEEDER ON THE STAPLE LINE OF THE GASTRIC REMNANT. THE SURGEON SUTURED LAPAROSCOPICALLY TO CONTROL THE BLEEDING. THE SURGEON INDICATED THAT A BLOOD TRANSFUSION WAS ALSO REQUIRED WITH A SUBSTANTIAL QUANTITY OF BLOOD PRODUCTS. THE PATIENT IS CURRENTLY DOING FINE. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 45 ENDOPATH STAPLER | NONE | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | RELOAD |