Pump, Air, Non-Manual, For Endoscope
FDA adverse event reports and recall history for pump, air, non-manual, for endoscope (product code FEQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,282
- Deaths
- 2
- Injuries
- 19
- Malfunctions
- 1,255
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-01Open, ClassifiedComponent change control
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- 2024-10-25Open, ClassifiedEquipment maintenance
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- 2015-10-08TerminatedProcess control
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
small puncture marks in a sterile package for an accessory to an Olympus device
- 2013-11-15TerminatedComponent design/selection
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.
- 2012-01-18TerminatedNonconforming Material/Component
Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
Water may leak from the irrigation tubing used on the Olympus Flushing Pump
Monitor pump, air, non-manual, for endoscope automatically
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