FDA Adverse Event
Malfunction
Summary report: N
SHOCKPULSE LITHOTRIPSY TRANSDUCER.
MDR report key: 21267158
·
Received January 29, 2025
Report
- Report Number
- 3011050570-2025-00076
- Event Type
- Malfunction
- Date Received
- January 29, 2025
- Report Date
- June 9, 2025
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- FEO
- PMA / PMN Number
- K142428
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
B5 CORRECTION: THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO A PREVIOUSLY SUBMITTED REPORT. THIS EVENT WAS REPORTED IS A DUPLICATE REPORT. PLEASE REFER TO MFG REPORT 3011050570-2024-10407-00 AND 3011050570-2024-10407-01.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE TRANSDUCER WAS NOT FUNCTIONING AT ALL WHEN THE BUTTON WAS PRESSED. THE ISSUE WAS FOUND DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER. DUPLICATE / INVALID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 534944 | SHOCKPULSE LITHOTRIPSY TRANSDUCER. | LITHOTRIPTOR, ULTRASONIC | FEO | GYRUS ACMI, INC. | SPL-T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |