FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60 ARTICULATING
MDR report key: 2061426
·
Received April 18, 2011
Report
- Report Number
- 1527736-2011-00092
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 25, 2011
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K081146
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED LAPAROSCOPIC COLECTOMY PROCEDURE, THE SURGEON FIRED THE DEVICE FOR THE SECOND FIRING WITH A BLUE CARTRIDGE. ONCE FIRED IT LOCKED ON TISSUE AND COULD NOT BE REMOVED. THE SURGEON PULLED THE DEVICE THROUGH THE TROCAR WITH THE TISSUE AND CUT THE DEVICE OFF OF THE TISSUE. THEY THEN STAPLED WITH A NEW LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON*FLEX60 ARTICULATING | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO SURGERY, INC (CINCINNATI) | UNK | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |