FDA Adverse Event
Malfunction
Summary report: N
MEDISTIM QUICKFIT TTFM PROBE
MDR report key: 23485250
·
Received November 6, 2025
Report
- Report Number
- 23485250
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- October 29, 2025
- Report Date
- October 30, 2025
- Manufacturer
- MEDISTIM ASA
- Product Code
- ITX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
MEDISTIM PROBE NO LONGER WORKING AFTER BEING PROCESSED. ATTEMPTED TO TROUBLESHOOT WITH REP AND NO SUCCESS. STILL HAS USES LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2682203 | MEDISTIM QUICKFIT TTFM PROBE | TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | MEDISTIM ASA | PQ100042 | 23803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |