BALLOON CONTROL UNIT OBCU (UDI 04953170237461)Recalls & reported problems
Olympus Medical Systems Corp. · "OBCU OLYMPUS BALLOON CONTROL UNIT (120V)" · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170237461), received between Sep 18, 2020 and Aug 12, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem2
- Overfill1
- Pressure Problem1
- Pumping Problem1
Patient problems
- Perforation2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Pressure Problem; Pumping Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222492 ↗InjurySep 18, 2020Inflation Problem; Inflation Problem
ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER 30SEP2020. THE PROCEDURE BEING PERFORMED WAS A THERAPEUTIC ENTEROSCOPY. NO OTHER DEVICES WERE INVOLVED IN THE EVENT. THE PROCEDURE WAS NOT COMPLETED, THE DEVICE FAILED AT THE BEGINNING OF THE PROCEDURE.
Patient problems: Perforation
MAUDE report 10555644 ↗InjurySep 18, 2020Inflation Problem; Overfill
THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND THE PATIENT. PROCEDURE: THERAPEUTIC SINGLE BALLOON ENTEROSCOPY. NO OTHER DEVICES WERE INVOLVED IN THE EVENT. THE PROCEDURE WAS NOT COMPLETED. THE DEVICE FAILED AT THE BEGINNING OF THE PROCEDURE.
Patient problems: Perforation
MAUDE report 10555535 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.