FDA Adverse Event
Malfunction
Summary report: N
EGIA 60 ARTICULATING XTRA THICK SULU
MDR report key: 3812613
·
Received April 17, 2014
Report
- Report Number
- 1219930-2014-00301
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 28, 2014
- Report Date
- March 28, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY US SUR
- Product Code
- GAG
- PMA / PMN Number
- K093410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: THORACO/LOBECTOMY. UPON USE ON THE THICK TISSUE, THE DEVICE STOPPED FIRING IN THE MIDDLE. REMOVED IT BY PRESSING THE SILVER BUTTON. LOADED A NEW SULU ON EGIAUSTND AND THEN CONFIRMED NO PROBLEM TO COMPLETE THE CASE. OPERATING TIME NOT EXTENDED NO PATIENT HARM. THE CUSTOMER DID NOT REPORT WHETHER REINFORCEMENT MATERIAL WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236270 | EGIA 60 ARTICULATING XTRA THICK SULU | DISPOSABLE SURGICAL STAPLER | GAG | COVIDIEN LP, FORMERLY US SUR | N3J0350X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IDRVULTRA1, IDRIVE ULTRA POWERED HANDLE 1,| K121410 |