HIGH FLOW INSUFFLATION UNIT UHI-3 (UDI 04953170140297)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus high flow insufflation unit supplies gas during laparoscopic surgery. Many of the 162 reports describe gas leaks, pressure problems, and units that fail to power up, often found during device evaluation. The reports include no deaths and 2 injuries. There is 1 open recall, started in January 2026, about a software issue that may lead to excess pressure.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 04953170140297), received between Sep 18, 2018 and Apr 21, 2026 — classified as 2 injuries, 160 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (20 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jan 16, 2026Open, Classified
Issue with software algorithm which may lead to overpressure events.
Z-1354-2026 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Gas/Air Leak20
- Pressure Problem16
- Failure to Power Up15
- Display or Visual Feedback Problem9
- Gas Output Problem8
- Improper Flow or Infusion8
- Electrical /Electronic Property Problem7
- Increase in Pressure7
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- No Consequences Or Impact To Patient19
- No Known Impact Or Consequence To Patient2
- Injury1
- Respiratory Insufficiency1
- Unspecified Respiratory Problem1
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Gas Output Problem; Material Deformation; No Visual Prompts/Feedback
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT HAD NO VALUE OF PRESSURE, THE FLOW RATE AND VOLUME WERE SHOWING ON THE FRONT PANEL ALTHOUGH NO GAS WAS BEING SUPPLIED DUE TO A FAULTY MAIN BOARD. ADDITIONALLY, THE TUBING WAS DIRTY AND YELLOWISH DUE TO A FAULTY TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940417 ↗MalfunctionApr 20, 2026Gas/Air Leak; Mechanical Jam
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT HAD A GAS LEAKAGE AND TUBE STUCK IN FIRST REGULATOR UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927488 ↗MalfunctionMar 31, 2026Loose or Intermittent Connection
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE ELECTROPNEUMATIC PROPORTIONAL VALVE UNIT WAS LOOSE ON THE HIGH FLOW INSUFFLATION UNIT. NO PATIENTS WERE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744443 ↗MalfunctionMar 3, 2026Gas/Air Leak; Material Integrity Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED GAS LEAKAGE FROM THE PRIMARY PIPING AND A LOOSE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497437 ↗MalfunctionMar 3, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED A SCRATCH ON THE PINCH VALVE AND A MALFUNCTIONING RELIEF MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494475 ↗MalfunctionFeb 20, 2026No Device Output; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT'S LEDS WERE FLICKERING BECAUSE THE FRONT PANEL IS DEPRESSED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402741 ↗MalfunctionFeb 5, 2026Gas/Air Leak
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268281 ↗MalfunctionJan 23, 2026Infusion or Flow Problem
IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT'S INSUFFLATION WAS NOT WORKING. THE ISSUE OCCURRED DURING SET UP OR INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24169025 ↗MalfunctionJan 13, 2026Break; Display or Visual Feedback Problem; Insufficient Flow or Under Infusion; Gas/Air Leak
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060720 ↗MalfunctionJan 5, 2026Gas Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959192 ↗MalfunctionDec 30, 2025Pressure Problem; Pressure Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924866 ↗MalfunctionDec 10, 2025Noise, Audible; Noise, Audible
IT WAS REPORTED THAT DURING DEVICE SERVICE AND MAINTENANCE, THE HIGH FLOW INSUFFLATION WAS NOT WORKING, WITH A LEAKAGE SOUND COMING FROM THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767509 ↗MalfunctionOct 15, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED LEAKAGE FROM INSUFFLATOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304747 ↗MalfunctionSep 16, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED MANIFOLD DAMPER WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066904 ↗MalfunctionJul 22, 2025Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565893 ↗MalfunctionJul 22, 2025Circuit Failure; Increase in Pressure; Circuit Failure; Increase in Pressure
IT WAS REPORTED THE INSUFFLATION UNIT PRESENTED A PRESSURE ALARM AND THE MAIN BOARD WAS NO GOOD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563660 ↗MalfunctionJul 3, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE SUBJECTED DEVICE PRESSURE DIFFERENCE IS TOO LARGE. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE (BEFORE PATIENT IN ROOM) THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22399459 ↗MalfunctionMay 19, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT THE SUBJECT DEVICE PRESENTED A PRESSURE ALARM. THE ISSUE WAS FOUND DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045243 ↗MalfunctionMay 2, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THE SUBJECT PRODUCT PRODUCED AN AIR LEAK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952950 ↗MalfunctionMay 1, 2025Failure to Power Up; Failure to Power Up
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21943498 ↗MalfunctionApr 25, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED INSUFFLATION IS TOO SLOW TO CONTINUE THE PROCEDURE. THE ISSUE OCCURRED DURING SERVICE / MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909734 ↗MalfunctionMar 27, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE SUBJECT DEVICE START BUTTON WAS OUT OF ORDER. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713536 ↗MalfunctionMar 19, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A POOR TOUCH PANEL. THIS ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE (DURING SETUP IN THE ROOM/BEFORE THE PATIENT WAS IN THE ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647133 ↗MalfunctionMar 11, 2025Device Alarm System; Activation Problem; Device Alarm System; Activation Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED OCCASIONAL STARTUP ALARM WITH BLACK SCREEN DUE TO FAULTY MAIN BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569925 ↗MalfunctionDec 13, 2024Pressure Problem; Pressure Problem
NO OTHER ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925057 ↗
Other INSUFFLATOR, LAPAROSCOPIC devices
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall48 reports
- AIRSEAL AS-iFS1Conmed Corporation · Insufflator, laparoscopic4 deaths93 reports
- Pneumosure 0620040610Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 death79 reports
- Pneumosure 0620040690Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall22 reports
- Pneumosure 0620040660Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall18 reports
- CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC58 reports
- STORZ 20400161SCanadian Hospital Specialties Limited · Insufflator, Laparoscopic1 recall0 reports
- Pneumosure 0620040680Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall0 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 · each recall links to the FDA recall notice
- 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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