PENTAX OF-B218Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04961333226153), received between Feb 19, 2024 and Feb 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE INITIAL REPORT, THE FIRST CAP[DEC] CLICKED ON BUT DETACHED BEFORE PATIENT USE, SECOND CAP[DEC] CLICKED ON BUT THEN DETACHED BEFORE PATIENT USE, THIRD CAP[DEC] ATTACHED AND WAS USED FOR A CASE AND HAD DIFFICULTIES REMOVING FROM THE ENDOSCOPE. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735969 ↗
• MalfunctionFeb 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE INITIAL REPORT, THE FIRST CAP[DEC] CLICKED ON BUT DETACHED BEFORE PATIENT USE, SECOND CAP[DEC] CLICKED ON BUT THEN DETACHED BEFORE PATIENT USE, THIRD CAP[DEC] ATTACHED AND WAS USED FOR A CASE AND HAD DIFFICULTIES REMOVING FROM THE ENDOSCOPE. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735968 ↗