FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60 ARTICULATING
MDR report key: 2120984
·
Received June 13, 2011
Report
- Report Number
- 3005075853-2011-02365
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 19, 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
- PA, 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 LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WHEN MAKING THE GASTRIC POUCH ON THE SECOND FIRING WITH A BLUE LOAD THE STAPLE LINE WAS BLEEDING. THE STAPLES WERE NOT FORMED WELL. THE SURGEON USED SUTURE TO OVER SEW THE STAPLE LINE. ALSO, THE OUTER ROW BY THE JEJUNUM, FURTHEST FROM THE KNIFE, THE STAPLES WERE NOT COMPLETELY FORMED. NO BLOOD TRANSFUSION WAS REQUIRED. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON*FLEX60 ARTICULATING | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |