Olympus SPL-PR376Recalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925043817), received between Jan 10, 2023 and Jan 10, 2023 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K142428); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fever1
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARISON OF SWISS LITHOCLAST® TRILOGY AND SHOCKPULSE-SE AS ENERGY SOURCE IN PERCUTANEOUS NEPHROLITHOTOMY FOR STAGHORN STONES: A MATCHED PAIR ANALYSIS." THIS STUDY AIMED TO EVALUATE EFFICACY OF SWISS LITHOCLAST TRILOGY (BOSTON SCIENTIFIC, USA) AND SHOCKPULSE-SE (OLYMPUS) IN PCNL FOR STAGHORN STONES IN 85 PATIENTS. TRILOGY HAD 81.48 % CLEARANCE AND SHOCKPULSE-SE HAD 61.53% CLEARANCE AT 48 HOURS IN FIRST STAGE PCNL. 18.51% PATIENTS OF TRILOGY AND 38.46% PATIENTS OF SHOCKPULSE-SE REQUIRED SUBSEQUENT STAGED PCNL. TRILOGY HAD 92.59% STONE FREE RATE AT 3-MONTH FOLLOW-UP WHILE SHOCKPULSE-SE HAD 80.76% STONE FREE RATE. AS PER THE STUDY RESULTS, TRILOGY HAS COMPARABLE STONE FRAGMENTATION RATE WITH SHOCKPULSE-SE IN MANAGING STAGHORN RENAL STONES. COMPLICATIONS AND INSTRUMENT MALFUNCTION WERE ALSO COMPARABLE FOR TRILOGY AND SHOCKPULSE-S. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS CLAVIEN-DINDO GRADE-II COMPLICATIONS -3 (UTI WITH FEVER) MALFUNCTIONS SUCTION BLOCK - 2 PROBE BREAKS - 3 THIS LITERATURE ARTICLE REQUIRES 6 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) (FOR CLAVIEN-DINDO GRADE-II COMPLICATIONS), (B)(6) (FOR SUCTIO
Patient problems: Fever; Urinary Tract Infection
MAUDE report 16132238 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142428. One submission often covers many models, so check the product and lot details in each record.
- Z-2197-2020 · Apr 23, 2020 · TerminatedOLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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