CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-1080 HOSE FOR CYLINDER PIN TYPE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus cylinder hose carries gas to a laparoscopic insufflator. The 61 reports mostly describe air or gas leaking from the hose, along with cracked or broken parts, connectors coming loose, and missing O-rings and other pieces. One report mentions an injury; no deaths were reported. No recalls name this device. Reports rose sharply in the past 12 months, from 7 to 30.
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
- 58
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 04953170140310), received between Oct 31, 2019 and Sep 15, 2026 — classified as 1 injury, 57 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (24 reports).
1 other recall cover devices cleared under the same FDA submission (K014166); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak24
- Break10
- Detachment of Device or Device Component10
- Component Missing9
- Leak/Splash4
- Crack2
- Component or Accessory Incompatibility1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Caustic/Chemical Burns1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Restricted Flow rate; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779575 ↗MalfunctionJun 19, 2026Break; Detachment of Device or Device Component
CUSTOMER CONTACT OLYMPUS TECHNICAL ASSISTANCE SUPPORT TO REPORT MISSING OR DAMAGED O-RINGS, INVOLVING OLYMPUS CYLINDER HOSE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563367 ↗MalfunctionMay 23, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD LEAKAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264178 ↗MalfunctionMay 6, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD LEAKING O-RING. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093847 ↗MalfunctionMay 5, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD A LEAK. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081083 ↗MalfunctionApr 21, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYLINDER HOSE EXHIBITED MISSING TANK CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942131 ↗MalfunctionApr 17, 2026Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913334 ↗MalfunctionApr 16, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD LEAKAGE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903494 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component; Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD GAS LEAKAGE AND MISSING TORIC JOINT (O RING). THE ISSUE WAS IDENTIFIED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885517 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component; Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD A O RING MISSING AND CAUSED A GAS LEAK. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873966 ↗MalfunctionApr 7, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD GAS LEAKAGE. THE ISSUE WAS FOUND DURING A SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800424 ↗MalfunctionApr 1, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT, THE PACKING JOINT (O-RING) OF CYLINDER HOSE WAS BROKEN AND IT SUBSEQUENTLY FELL OFF. THE ISSUE WAS IDENTIFIED AT THE TIME OF INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24759869 ↗MalfunctionMar 31, 2026Gas/Air Leak
IT WAS REPORTED THAT THE CYLINDER HOSE HAD A FAILING SEAL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746367 ↗MalfunctionMar 25, 2026Gas/Air Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING ENDOSCOPY PROCEDURE WHILE SWITCHING TANK, THE CYLINDER HOSE HAD RIPPED PACKING JOINT AND WAS LEAKING CARBON DIOXIDE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691243 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component; Gas/Air Leak
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYLINDER HOSE HAD EXHIBITED A LEAK FROM THE CLAMP SECTION DUE TO A MISSING PACKING JOINT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547047 ↗MalfunctionMar 4, 2026Break; Insufficient Device Problem Information
IT WAS REPORTED THE CYLINDER HOSE PRESENTED A BREAKDOWN ON THE O-RING OF THE CO2 HOSE. THE ISSUE OCCURRED DURING MAINTENANCE, NOT IN A CLINICAL SETTING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512747 ↗MalfunctionFeb 27, 2026Break
IT WAS REPORTED THAT THE CYLINDER HOSE HAD A PIN THAT IS BROKEN. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469743 ↗MalfunctionFeb 20, 2026Component Missing
IT WAS REPORTED THAT THE CYLINDER HOSE HAD LOST THE PACKING JOINT (O-RING). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405167 ↗MalfunctionFeb 16, 2026Component Missing
IT WAS REPORTED THAT THE CYLINDER HOSE EXHIBITED A METAL HANDLE, WITH THE PACKING JOINT O-RING AND O-RING STOPPER MISSING. THIS ISSUE WAS IDENTIFIED DURING A PRE-USE INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360847 ↗MalfunctionJan 27, 2026Leak/Splash; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CYLINDER HOSE EXHIBITED MISSING O-RING AND THE UNIT WAS LEAKING AT THE CONNECTION POINT. THE EVENT OCCURRED DURING SERVICE MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193087 ↗MalfunctionDec 29, 2025Component Missing; Component Missing
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919154 ↗MalfunctionDec 23, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE CYLINDER HOSE HAD A MISSING O-RING MISSING DURING AN INSPECTION FOR USE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23885289 ↗MalfunctionDec 23, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881228 ↗MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CYLINDER HOSE EXHIBITED MISSING O-RINGS (TORIC JOINT). THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878680 ↗MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876526 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K014166. One submission often covers many models, so check the product and lot details in each record.
- Z-1354-2026 · Jan 16, 2026 · Open, ClassifiedOlympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic obs
Other INSUFFLATOR, LAPAROSCOPIC devices
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall162 reports
- 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
- Pneumosure 0620040680Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall0 reports
- STORZ 20400161SCanadian Hospital Specialties Limited · 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 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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