PENTAX OF-B120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04961333070435), received between Jul 24, 2021 and Aug 4, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2021Break; Break

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE SEALED RING OF THE SUCTION VALVE DROPS AFTER HALF OF YEAR WHICH CAUSE THE SUCTION FUNCTION HAPPENED TO THE DEFECT. WHEN THE MALFUNCTION IS SERIOUS, THE USER CAN'T DO THE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272341 ↗
• MalfunctionJul 31, 2021Break; Break

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.THE SEAL RING OF THE SUCTION VALVE DROPS AFTER USING HALF OF YEAR; IT CAUSES THE SUCTION VALVE HAPPENED TO THE DEFECT. WHEN IT IS SERIOUS, THE USER CANN'T DO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257136 ↗
• MalfunctionJul 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE BLACK RING IN THE VALVE GET LOST AND SO THERE IS A PERMANENT SUCTION. THIS HAPPENS WITH 16 VALVES WITHIN THIS CUSTOMER. WE COLLECTED THE VALVES FOR FURTHER INVESTIGATION IF THIS IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250893 ↗
• MalfunctionJul 26, 2021Material Integrity Problem; Material Integrity Problem

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE SEALED RING OF THE SUCTION VALVE AFTER USING HALF OF YEAR; IT WILL CAUSE THE MALFUNCTION OF THE SUCTION. WHEN THE MALFUNCTION IS SERIOUS, THE USER CAN'T DO THE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223343 ↗
• MalfunctionJul 24, 2021Break; Break

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE SUCTION VALVE WAS USED FOR HALF OF YEAR; THE SEALED RING DROPS AND IT AFFECTED FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222453 ↗