FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60 ARTICULATING
MDR report key: 2122807
·
Received June 14, 2011
Report
- Report Number
- 3005075853-2011-02397
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 10, 2011
- Report Date
- May 23, 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
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, THE SURGEON WAS UNABLE TO OPEN THE DEVICE AFTER IT WAS FIRED. IT WAS LOCKED ON COLON TISSUE. THEY PULLED THE TISSUE OUT OF THE JAW. NO TISSUE TRAUMA REPORTED. 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 |