FDA Adverse Event
Malfunction
Summary report: N
SHOCKPULSE-SE LITHOTRIPSY SYSTEM
MDR report key: 19140060
·
Received April 18, 2024
Report
- Report Number
- 3011050570-2024-10071
- Event Type
- Malfunction
- Date Received
- April 18, 2024
- Date of Event
- March 20, 2024
- Report Date
- July 24, 2024
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- FEO
- PMA / PMN Number
- K142428
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
TO DATE, THE DEVICE HAS NOT BEEN RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUPPLEMENTED FOR CORRECTION TO THE INITIAL MEDWATCH (REPORT REFERENCE NUMBER: 3011050570-2024-10071), WHICH WAS SUBMITTED IN ERROR. THERE WAS NO MALFUNCTION WITH REGARD TO THE SUBJECT DEVICE SPL-G.
Description of Event or Problem · 0
IT WAS REPORTED, THE SUBJECT DEVICE HAD A CRACKED CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED, THE SUBJECT DEVICE HAD A CRACKED CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2583287 | SHOCKPULSE-SE LITHOTRIPSY SYSTEM | LITHOTRIPTOR, ULTRASONIC | FEO | GYRUS ACMI, INC. | SPL-G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |