TITAN SGS
Report
- Report Number
- 3012481535-2022-00003
- Event Type
- Malfunction
- Date Received
- August 14, 2022
- Date of Event
- July 18, 2022
- Report Date
- August 14, 2022
- Manufacturer
- STANDARD BARIATRICS, INC.
- Product Code
- GDW
- UDI-DI
- 0085167707089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED TO STANDARD BARIATRICS FOR EVALUATION. INVESTIGATION FOUND THAT THERE WAS DAMAGE TO THE CLOSURE SYSTEM WHICH LED TO THE DEVICE BEING INOPERABLE. THE ROOT CAUSE WAS ATTRIBUTED TO EXCESSIVE FORCE/ROTATIONS BEING APPLIED BY THE USER TO THE CLOSURE SYSTEM WHILE ATTEMPTING TO MANUALLY OPEN THE JAWS OF THE DEVICE USING THE BAILOUT KEY; RESULTING IN THE DEVICE BEING STUCK IN THE OPEN POSITION.
DURING A SLEEVE GASTRECTOMY PROCEDURE, THE TITAN SGS SYSTEM STOPPED MID-WAY DURING FIRING AND PROMPTED THE USER TO MANUALLY BAIL OUT THE DEVICE. DURING MANUAL BAIL OUT AND USING THE BAILOUT KEY PROVIDED, THE USER RESET THE KNIFE, AND WAS ABLE TO OPEN THE TTIAN SGS JAWS TO RELEASE FROM THE STOMACH. IT WAS REPORTED THAT THE USER TURNED THE BAILOUT KEY 20-40 TIMES TO OPEN THE JAWS. THE USER WAS UNABLE TO CLOSE THE DEVICE USING THE BAILOUT KEY, WHICH RESULTED IN THE PATIENT'S INCISION SITE TO BE INCREASED TO ALLOW FOR THE REMOVAL OF THE TITAN SGS WITH THE JAWS IN THE OPEN POSITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STAPLER, WITH NO OBSERVED LEAKS. THE PROCEDURE WAS PROLONGED, APPROXIMATELY 15 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2790923 | TITAN SGS | STAPLE, IMPLANTABLE | GDW | STANDARD BARIATRICS, INC. | SGS23R | 077-22 | 0085167707089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |