FDA Adverse Event
Malfunction
Summary report: N
ENDO GIA ADAPTER STANDARD
MDR report key: 3973261
·
Received June 6, 2014
Report
- Report Number
- 1219930-2014-00426
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 14, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K121510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAPAROSCOPIC SIGMOIDECTOMY. ACCORDING TO THE REPORTER: NO PROBLEM IN SETTING ADAPTER. HOWEVER EVEN AFTER SETTING THE CARTRIDGE, CALIBRATIONS WOULD NOT START. SETTING IT AGAIN FOR SEVERAL TIMES, FOUND THE JAW OF CARTRIDGE COULD BE OPENED AND CLOSED EVEN WITHOUT PERFORMING THE CALIBRATIONS. LATER EVEN WITHOUT PRESSING THE TOGGLE SWITCH, THE DEVICE ARTICULATED ON THE LEFT. ALSO CONFIRMED ABNORMAL CONDITIONS OF LIGHTING OF INDICATOR LAMPS. CONFIRMED IT COULD NOT WORK NORMALLY WHEN IT WAS MOVED AWAY THE SURGICAL FIELD. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO EXTENDED. UNK USE OF REINFORCEMENT MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331417 | ENDO GIA ADAPTER STANDARD | REUSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL | N3G0266UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MFG DATE: 08/2013| EXP. DATE: 01/31/2019, MFG DATE: 01/2014| IDRIVE ULTRA POWERED HANDLE 1, IDRVULTRA1,| EGIA 60 ARTICULATING MED/THICK SULU, EGIA60AMT,| LOT# N4A1185KX, K083519| LOT #N3H0395UX, SERIAL # (B)(4), K121510 |