BALLOON3 MAJ-233 (UDI 04953170360428)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170360428), received between Jul 6, 2021 and Jan 10, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- No Apparent Adverse Event1
- Separation Failure1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE WATER BALLOON WAS FOUND TO BE LEAKING UPON INSTALLATION. THIS CAUSED A 30-MINUTE DELAY OR GREATER DURING A DIAGNOSTIC ENDOSCOPIC ULTRASOUND. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129840 ↗InjuryJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE WATER BALLOON WAS FOUND TO BE LEAKING UPON UNPACKING. THIS CAUSED A 30-MINUTE DELAY OR GREATER DURING A DIAGNOSTIC ENDOSCOPIC ULTRASOUND. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE AND THERE WERE NO REPORTS OF FURTHER PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120256 ↗MalfunctionMar 28, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE BALLOON3 HAD A TEAR WHEN COMING OFF THE ENDOSCOPE. TEARING RESULTED IN SMALL RIM OF RUBBER REMAINING ON THE SCOPE WHICH IS NEARLY INVISIBLE TO THE NAKED EYE AS NATURAL RUBBER ON SILVER COLORED METAL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997974 ↗MalfunctionNov 30, 2023No Apparent Adverse Event; No Apparent Adverse Event
ADDITIONAL INFORMATION INDICATES THE EVENT OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC ULTRASOUND PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243742 ↗MalfunctionJul 6, 2021Separation Failure; Separation Failure
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY WHO HAS ADVISED THE FOLLOWING; "THE RIM OF THE BALLOON BECAME CAUGHT IN THE RIDGE ON THE END OF THE SCOPE AND IT WAS STUCK SO THEY WERE UNABLE TO REMOVE IT. IN ORDER TO CARRY OUT THE PROCEDURE HE HAD TO FIT A SECOND BALLOON OVER THE TOP". THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12119929 ↗
Other Colonoscope and accessories, flexible/rigid devices
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- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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