Olympus WA22810ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761051729), received between Mar 11, 2024 and Apr 22, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (6 reports).

2 FDA recall records name this device's identifier, 2 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 16, 2026.

Recalls naming this device

1. Sep 13, 2024Open, Classified

   Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

   Z-0351-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 13, 2024Open, Classified

   Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

   Z-1437-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Degraded; Degraded

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE OUTER SHEATH EXHIBITED NUMEROUS SPARK MARKS AT THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160087 ↗
• MalfunctionMar 26, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE ISSUE WAS FOUND DURING REPROCESSING FOR A THERAPEUTIC LASER VAPORIZATION OF PROSTATE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979464 ↗
• MalfunctionMar 26, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE ISSUE WAS FOUND DURING REPROCESSING FOR A THERAPEUTIC LASER VAPORIZATION OF PROSTATE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979356 ↗
• MalfunctionMar 26, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE RIGID ENDOSCOPE SHEATH'S DISTAL TIP WAS BURNT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979305 ↗
• MalfunctionMar 26, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE ISSUE WAS FOUND DURING REPROCESSING FOR A THERAPEUTIC LASER VAPORIZATION OF PROSTATE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978795 ↗
• MalfunctionMar 26, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE ISSUE WAS FOUND DURING REPROCESSING FOR A THERAPEUTIC LASER VAPORIZATION OF PROSTATE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978704 ↗
• MalfunctionMar 18, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED, THE OUTER SHEATH, 22.5 FR. EXHIBITED A BURNT DISTAL TIP. THE ISSUE OCCURRED DURING REPROCESSING FOR A THERAPEUTIC LASER VAPORIZATION OF PROSTATE PROCEDURE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923518 ↗
• MalfunctionMar 11, 2024Sparking; Sparking

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OUTER SHEATH EXHIBITED MANY SPARK MARKS WERE CONFIRMED AT THE TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881743 ↗