FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60 LONG
MDR report key: 2043437
·
Received April 7, 2011
Report
- Report Number
- 3005075853-2011-01399
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 14, 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
- NC, 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, AFTER FIRING THE DEVICE IT WAS NOTICED THAT THE TISSUE OPENED UP DUE TO THE STAPLES NOT FORMING COMPLETELY. THE PROBLEM WAS NOTICED AFTER THE 9TH OR 10TH FIRING WHILE USING A WHITE RELOAD DURING THE CLOSURE OF THE ROUX LIMB. THE SAME DEVICE WAS FIRED AGAIN ON THE JEJUNUM USING A WHITE RELOAD AND IT WAS NOTICED THAT THE STAPLE LINE LATERAL TO THE CUT LINE WAS OPEN. THE SURGEON OVER-SEWED THE STAPLE LINE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. 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 |