FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60 LONG
MDR report key: 2111618
·
Received June 2, 2011
Report
- Report Number
- 3005075853-2011-02243
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 10, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K081146
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, ON THE THIRD FIRING, USING A BLUE CARTRIDGE TO CLOSE THE JEJUNOJEJUNOSTOMY, THE STAPLE LINE WAS INCOMPLETE DISTALLY. FURTHER FIRINGS WITH THE SAME STAPLER WERE ALL FINE, INCLUDING THICK TISSUE FIRINGS ON THE STOMACH. SHE COMPLETED THE STAPLE LINE BY HAND-SEWING IT. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON*FLEX60 LONG | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |