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Device brand name · Fluid jet removal system
AquaBeam Robotic System: medical device reports filed with FDA
1,191 reports name it, 2019–2026. Manufacturer given most often on reports: Procept Biorobotics. Product code PZP.
- 1,191
- device reports naming the brand
- 0% of all MAUDE reports · about 168 a year
- 113
- reports, 12 months to August 2026
- 235 in the 12 months before
- 46.2%
- classified as malfunction
- 45.6% across the product code
- 2.2%
- classified as death, as reported
- 26 reports · not verified by FDA
FDA's MAUDE database holds 1,191 reports that name the brand "AquaBeam Robotic System" (fluid jet removal system), received between June 2019 and August 2026; the manufacturer given most often on reports is Procept Biorobotics. Spellings of one product vary from report to report.
113 reports arrived in the 12 months to August 2026, down 52% from 235 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (51.6%), malfunction (46.2%) and death (2.2%); across all fluid jet removal system reports (product code PZP) death is recorded in 2.4% and malfunction in 45.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are visual prompts will not clear (19.4%), display or visual feedback problem (7.4%) and connection problem (5.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, perforation and urinary retention. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,475 reports carrying product code PZP. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Visual prompts will not clear | 231 | 19.4% | 19.3% |
| Display or visual feedback problem | 88 | 7.4% | 6.3% |
| Connection problema connection problem | 61 | 5.1% | 5.2% |
| Breakthe device broke | 45 | 3.8% | 3.2% |
| Mechanical problema mechanical problem | 44 | 3.7% | 3.2% |
| No flow | 18 | 1.5% | 1.4% |
| Mechanical jam | 17 | 1.4% | 1.3% |
| Infusion or flow problema problem with flow or infusion | 14 | 1.2% | 0.9% |
| Failure to align | 13 | 1.1% | 0.9% |
| Failure to prime | 13 | 1.1% | 1.1% |
| Audible prompt/feedback problem | 12 | 1% | 0.8% |
| Material twisted/bent | 9 | 0.8% | 0.6% |
| Output problem | 9 | 0.8% | 0.6% |
| Detachment of device or device componentpart of the device came off | 8 | 0.7% | 0.5% |
| Firing problem | 8 | 0.7% | 0.6% |
| Poor quality image | 8 | 0.7% | 0.7% |
| Suction failure | 8 | 0.7% | 0.5% |
| Failure to power up | 7 | 0.6% | 0.5% |
| Incomplete or inadequate connection | 7 | 0.6% | 0.6% |
| Moisture damage | 7 | 0.6% | 0.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 305 | 25.6% |
| Perforation | 134 | 11.3% |
| Urinary retentionbeing unable to empty the bladder | 43 | 3.6% |
| Cardiac arrestthe heart stopped | 26 | 2.2% |
| Low blood pressure/ hypotension | 25 | 2.1% |
| Urethral stenosis/stricture | 23 | 1.9% |
| Pulmonary embolisma blood clot in the lung | 22 | 1.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 21 | 1.8% |
| Sexual dysfunctiona sexual problem | 20 | 1.7% |
| Laceration(s) | 19 | 1.6% |
| Urinary tract infectionbladder or urinary infection | 16 | 1.3% |
| Hematuria | 11 | 0.9% |
| Incontinence | 9 | 0.8% |
| Embolism/embolus | 6 | 0.5% |
| Urinary incontinenceleaking urine | 6 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AquaBeam Robotic System | Product code PZP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,191 | 1,475 | 26,136,888 |
| Share of that pool | — | 80.7% | 0% |
| Classified as death, per 1,000 reports | 22 | 24 | 9 |
| Classified as injury | 51.6% | 51.9% | 36.2% |
| Classified as malfunction | 46.2% | 45.6% | 62.3% |
| Filed by the manufacturer | 100% | 98.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PZP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| HYDROS Robotic System | 164 | 125 | 3% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about AquaBeam Robotic System reports
How many FDA reports name AquaBeam Robotic System?
1,191 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 113 in the latest 12 months.
What kinds of events are reported?
injury (51.6%), malfunction (46.2%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
visual prompts will not clear (19.4%), display or visual feedback problem (7.4%), connection problem (5.1%), break (3.8%) and mechanical problem (3.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that AquaBeam Robotic System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.