FDA Adverse Event
Malfunction
Summary report: N
LITHODIAMOND LITHOTRIPTER
MDR report key: 8363563
·
Received February 22, 2019
Report
- Report Number
- 3005655081-2019-00001
- Event Type
- Malfunction
- Date Received
- February 22, 2019
- Date of Event
- February 11, 2019
- Report Date
- February 11, 2019
- Manufacturer
- HEALTHTRONICS, INC.
- Product Code
- LNS
- PMA / PMN Number
- K021775
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
FROM (B)(4) ON (B)(6) 2019 STATES, "UNABLE TO DUPLICATE HIGH VOLTAGE SHOCKWAVE ERROR. SYSTEM TESTED IAW MANUFACTURER'S SERVICE MANUAL AND IS FULLY OPERATIONAL." DEVICE RETURNED TO CUSTOMER. EVENT OCCURRED DURING PROCEDURE WITH THE PATIENT UNDER ANESTHESIA AND THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. HOWEVER, THERE WAS NO PATIENT INJURY AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.
Additional Manufacturer Narrative · 1
WAITING FOR FIELD SERVICE REPORT FOR EVALUATION OF DEVICE.
Description of Event or Problem · 1
HIGH VOLTAGE ERROR CHU213. THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE, BUT THE CASE WAS COMPLETED. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157746 | LITHODIAMOND LITHOTRIPTER | LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE, UROLOGICAL | LNS | HEALTHTRONICS, INC. | LITHODIAMOND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |