Model note · PCNL System

Olympus ShockPulse-SE Lithotripsy System

Name: Olympus ShockPulse-SE Lithotripsy System
Brand: Olympus ShockPulse

ShockPulse-SE is an intracorporeal lithotripter for urinary stones in the kidney, ureter and bladder, used through an endoscope. A reusable transducer converts electrical energy into ultrasonic vibration that travels down a probe to break up stones, and the system aspirates stone debris. It comprises a generator (SPL-G), transducer (SPL-T) and single use or reusable probes, with an optional footswitch.

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The model

Maker, model and type.

Maker: Olympus (manufactured by Cybersonics, Inc.)
Model: ShockPulse-SE Lithotripsy System
Device type: PCNL System
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Components	Generator, probes, transducer, cleaning stylet, wrench, power cord, nosecone; optional footswitch	Source
Principle	Transducer converts electrical energy into ultrasonic vibration that travels down the probe; stone debris is aspirated	Source
Output and frequency	Maximum 100 W ultrasonic output to the transducer; 19,500 to 21,500 Hz	Source
Probes	3.76, 3.40, 1.83, 1.50 and 0.97 mm; 304 stainless steel (larger sizes with diamond like carbon coating); single use EtO sterile or reusable steam sterilised (prevac)	Source
Model numbers	Generator SPL-G; transducer SPL-T; probes SPL-S (single use) and SPL-SR (reusable)	Source
Applied part and indications	Type BF; fragmentation of urinary tract calculi in the kidney, ureter and bladder	Source
FDA clearance	K171024 (August 2017), predicate K142428; product code FEO	Source

Recalls

Known FDA recalls.

Z-1494-20262026-01-08
Mis wired component adds power supply noise outside EMC standards (further serial numbers).
FDA record
Z-1479-20262025-11-14
Generator may stay blinking without recognising the transducer; plug or receptacle damage (also Z-1477 and Z-1478-2026 for probes).
FDA record
Z-0452-20262025-10-08
Transducer may fail to start or stop with an error light, and the handpiece may warm in use.
FDA record
Z-1514-20222022-07-07
Mis wired generator component causing power supply noise.
FDA record
Z-2197-20202020-04-23
Transducer component of non conforming material could allow water ingress during autoclaving.
FDA record

Safety

Safety warnings from the record.

The transducer handpiece can grow hot during use on affected units. Source
Device failure mid procedure delays treatment, so a backup set is part of the cleared labelling. Source
Probe breakage is frequently reported; inspect probes and retrieve fragments. Source

Sources

Where this note comes from.

Not covered: The Olympus IFU was not opened, so front panel indicators, power settings, reprocessing limits and probe life are missing. Recall records were read through openFDA. MAUDE counts may include bulk reports.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

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