Lithotripsy Probe, Sterile Single Use ShockPulse-SE, 10.2 Fr (3.40mm) X 396mm SPL-PD340Recalls & reported problems
Cybersonics Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855279005122), received between Sep 26, 2017 and Sep 26, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Metal Shedding Debris” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Metal Shedding Debris1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2017Metal Shedding Debris; Metal Shedding Debris
DESCRIPTION PROVIDED BY DISTRIBUTOR. "SPL-PR340 PROBE (LOT NO. W1504338) IS USED IN A PCNL CASE PERFORMED BY UROLOGIST. THIS PHENOMENON OCCURRED DURING THE 2ND TIME OF USAGE. THE PROBE WAS UNPACKED AND ACTIVATED WITH HAND SWITCH BY A DOCTOR. DURING PROCEDURE, A SMALL GLITTER FRAGMENTS; PROBABLY A COATING OF SHOCKPULSE PROBES WAS PEEL OFF ON THE PATIENT'S KIDNEY. DOCTOR HAS REMOVED THOSE FRAGMENTS AND MOST OF THE FRAGMENTS HAVE BEEN REMOVED COMPLETELY EXCEPT FOR VERY SMALL PIECES. THE RESULT OF THE OPERATION / SURGERY WAS COMPLETED SAFELY. AFTER THE CASE, THE SUBJECTED PRODUCT HAS BEEN FOUND THAT THE SURFACE OF PROBE WAS SCRATCHED ALTHOUGH THIS CASE WAS JUST THE SECOND TIME OF USING". MODEL NO. OF PROBES MENTIONED IN COMPLAINT FROM DISTRIBUTOR: SPL-PR340 (REUSABLE). ACTUAL MODEL NO. OF PROBES SHIPPED TO DISTRIBUTOR: SPL-PDBX340 (SINGLE USE, DISPOSABLE PROBES).
Patient problems: Foreign Body In Patient
MAUDE report 6893665 ↗
Other Lithotriptor, Ultrasonic devices
- ShockPulse SPL-TGyrus ACMI, LLC · Lithotriptor, ultrasonic279 reports
- ShockPulse SPL-SGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls159 reports
- SHOCKPULSE SPL-SRGyrus ACMI, LLC · Lithotriptor, Ultrasonic2 recalls97 reports
- ShockPulse SPL-GGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls10 reports
- Lithotripsy Transducer ShockPulse-SE SPL-TCybersonics Inc · Lithotriptor, Ultrasonic1 recall24 reports
- ShockPulse SPL-FSGyrus ACMI, LLC · Lithotriptor, ultrasonic20 reports
- ShockPulse Lithotripsy Generator SPL-GCybersonics Inc · Lithotriptor, Ultrasonic8 reports
- Lithotripsy System ShockPulse-SE SPL-SCybersonics Inc · Lithotriptor, Ultrasonic7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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