FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60 LONG
MDR report key: 2061471
·
Received April 18, 2011
Report
- Report Number
- 3005075853-2011-01543
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 25, 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
- TX, 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 SLEEVE GASTRECTOMY PROCEDURE, AFTER THE FIRST FIRING OF THE DEVICE, MALFORMED STAPLES WERE NOTICED ON THE PROXIMAL ONE-THIRD OF THE STAPLE LINE. SOME BLEEDING WAS NOTICED WHICH WAS CONTROLLED USING CLIPS AND FIBRIN SEALANT. 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 | (B)(4) |