FDA Adverse Event
Malfunction
Summary report: N
TRUFREEZE SPRAY CRYOTHERAPY SYSTEM
MDR report key: 11609554
·
Received April 2, 2021
Report
- Report Number
- 1528319-2021-00012
- Event Type
- Malfunction
- Date Received
- April 2, 2021
- Date of Event
- March 4, 2021
- Report Date
- April 2, 2021
- Manufacturer
- UNITED STATES ENDOSCOPY GROUP, INC.
- Product Code
- GEH
- PMA / PMN Number
- K172041
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A STERIS SERVICE SPECIALIST ARRIVED ONSITE AND DETERMINED THAT THE CONSOLE WAS NOT RECOGNIZING THE DATA ACQUISITION MODULE (DAQ MODULE), WHICH IS A SELF-CONTAINED ELECTRONIC CARTRIDGE. THE SERVICE SPECIALIST REPLACED THE DAQ MODULE, TESTED THE UNIT, CONFIRMED IT TO BE WORKING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THE TRUFREEZE CONSOLE CC301 FAILED A BUILT-IN TEST AT START UP, LEADING TO THE POSTPONEMENT OF A PLANNED PROCEDURE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504016 | TRUFREEZE SPRAY CRYOTHERAPY SYSTEM | CRYOTHERAPY SYSTEM | GEH | UNITED STATES ENDOSCOPY GROUP, INC. | CC301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |