Olympus WAIR100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04042761083621), received between Jul 20, 2022 and Mar 24, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A DETACHED DISTAL TERMINAL LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673300 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A SHIFTED TUBE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246294 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE SUBJECT DEVICE HAS ITS COVER GLASS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22876547 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THE OPTICS IN THE RIGID ENDOSCOPE TELESCOPE HAD FALLEN AND THE BLACK PIECE HAD BROKEN. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437772 ↗
• MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THE TELESCOPE HAD LENS BREAKAGE AND LIQUID ENTRY DURING STERILIZATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391701 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE DISTAL TIP GLASS OF THE TELESCOPE IS SHATTERED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652716 ↗
• MalfunctionFeb 29, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNKNOWN LAPAROSCOPIC PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809069 ↗
• MalfunctionDec 11, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS RIGID SCOPE HAD A DAMAGED TIP. THE ISSUE WAS ASSOCIATED WITH A THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE TIP COVER GLASS WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307485 ↗
• MalfunctionOct 30, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE LIGHT GUIDE CAP OF THE SCOPE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035644 ↗
• MalfunctionFeb 16, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, THE TELESCOPE HAD EXCESSIVE DAMAGE AND DENTS IN THE SHAFT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390958 ↗
• MalfunctionJan 24, 2023Break; Break

  OLYMPUS (OMSC) WAS INFORMED THE CUSTOMER IR, AUTOCLAVABLE RIGID TELESCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR A REPORTED ¿OBJECTIVE LENS IS DOWN¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT AN UNSPECIFIED EVENT. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. UPON INSPECTING, THE MISALIGNMENT OF THE OBJECTIVE LENS AT THE DISTAL END OF THE SCOPE ATTRIBUTING TO A CROPPED IMAGE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE MISALIGNMENT OF THE OBJECTIVE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231400 ↗
• InjuryJul 20, 2022Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC PROCEDURE FOR DETECTION OF SENTINEL LYMPH NODES, AN INCORRECT DEVICE WAS PROVIDED IN THE INSTRUMENT KIT (A TELESCOPE "ULTRA", 10 MM, 0° (WA4KL100, SN# (B)(4)) WAS IN THE BOX OF THE WAIR100A KIT (TELESCOPE "IR", 10 MM, 0°)) WITH THE EFFECT THAT THE INTENDED INFRARED FLUORESCENCE EXAMINATION COULD NOT BE PERFORMED. INSTEAD, A MORE INVASIVE PROCEDURE WITH A DOUBLE CURAGE LEFT AND RIGHT WAS PERFORMED. HOWEVER, THE PATIENT IS REPORTEDLY WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15063242 ↗