SINGLE USE BIOPSY VALVE MAJ-1218Recalls & reported problems
Olympus Medical Systems Corp. · SINGLE USE BIOPSY VALVE MAJ-1218 · Class 2
All models of SINGLE USE BIOPSY VALVE (3)
Data updated Oct 18, 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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14953170154291), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jan 29, 2026Class IIOpen, Classified
Potential for rubber fragment detachment during use.
Z-1489-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE OTORHINOLARYNGOLOGY OUTPATIENT EXAMINATION USING THE SINGLE USE BIOPSY VALVE WITH THE RHINOLARYNGOSCOPE, A BLACK PIECE OF RUBBER FELL INTO THE FIELD OF VIEW. THE BLACK RUBBER PIECE WAS COLLECTED USING BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED WITH NO EFFECT ON THE DIAGNOSIS OR TREATMENT OUTCOME. THE FALLEN PIECE WAS 1 TO 2MM AND HAD NO SHARP PARTS. THE PROCEDURE WAS DELAYED A FEW MINUTES WHILE THE FOREIGN BODY WAS COLLECTED WITH BIOPSY FORCEPS. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ABNORMALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084854 ↗
Other Nasopharyngoscope (Flexible Or Rigid) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Olympus Medical Systems Corp. · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 recalls1 death408 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- SINGLE USE SUCTION VALVE MAJ-209Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)228 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 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 · each recall links to the FDA recall notice
- 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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