FDA Adverse Event
Malfunction
Summary report: N
SAVI SCOUT®
MDR report key: 13590980
·
Received February 24, 2022
Report
- Report Number
- 13590980
- Event Type
- Malfunction
- Date Received
- February 24, 2022
- Date of Event
- February 8, 2022
- Report Date
- February 10, 2022
- Manufacturer
- CIANNA MEDICAL, INC.
- Product Code
- NEU
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SAVI SCOUT HAND PIECE COULD NOT PROPERLY CONNECT TO MACHINE. TRIED TO USE ANOTHER OFF STERILE FIELD HAND PIECE AND WOULD NOT CONNECT EITHER. A NEW HAND PIECE WAS PLACED ON STERILE FIELD AND WORKED PROPERLY.
Description of Event or Problem · 0
SAVI SCOUT HAND PIECE COULD NOT PROPERLY CONNECT TO MACHINE. TRIED TO USE ANOTHER OFF STERILE FIELD HAND PIECE AND WOULD NOT CONNECT EITHER. A NEW HAND PIECE WAS PLACED ON STERILE FIELD AND WORKED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65514 | SAVI SCOUT® | MARKER, RADIOGRAPHIC, IMPLANTABLE | NEU | CIANNA MEDICAL, INC. | HPSU-01 | H2256551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |