Olympus WA22606SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14042761085158), received between Sep 9, 2019 and Sep 19, 2024 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024

  THE BIPOLAR SET WAS BROKEN SUCH THAT VISUALIZATION WAS SO BAD IT WAS UNSAFE TO CONTINUE WITH THE SURGERY. VISION WAS OK AT THE BEGINNING OF THE CASE BUT AS SOON AS THERE WAS SOME BLEEDING, VISUALIZATION DETERIORATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20256068 ↗
• MalfunctionMar 23, 2023Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONFIRMED THE PROCEDURE WAS THERAPEUTIC AND THE REPORTED PROBLEM DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16606301 ↗
• MalfunctionMar 10, 2023Break; Mechanical Problem; Break; Mechanical Problem

  OLYMPUS RECEIVED A MEDSUN (B)(4) REPORT WITH AN EVENT/ PROBLEM REPORTED OF "WHILE RESECTING PROSTATE DURING A TRANSURETHRAL RESECTION PROSTATE SURGERY THE LOOP ELECTRODE GOT CAUGHT WHILE IN THE PATIENT ON A UROLIFT CLIP AND THE LOOP BROKE INTO 2 PIECES BOTH PIECES. NO HARM TO PATIENT. THE BIPOLAR TRANSURETHRAL RESECTION OF PROSTATE WAS COMPLETED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519965 ↗
• MalfunctionFeb 10, 2023Break

  WHILE RESECTING PROSTATE DURING A TRANSURETHRAL RESECTION PROSTATE SURGERY THE LOOP ELECTRODE GOT CAUGHT WHILE IN THE PATIENT ON A UROLIFT CLIP AND THE LOOP BROKE INTO 2 PIECES BOTH PIECES. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351089 ↗
• MalfunctionJan 20, 2023Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HF-RESECTION ELECTRODE "PLASMALOOP", (LOOP, MEDIUM, 24 FR., 12°-30°, PK TURIS), THE CAUTERY PIECE WAS NOT CAUTERIZING WELL. THE ISSUE OCCURRED DURING THE DIAGNOSTIC PROCEDURE (TRANSURETHRAL BLADDER TUMOR EXCISION), AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214412 ↗
• MalfunctionNov 15, 2021Output Problem

  DURING CYSTO, USING THE OLYMPUS BIPOLAR LOOP FOR CAUTERIZING THE BLADDER. THE LOOP WAS OPENED AND CONNECTED TO GYRUS MACHINE. THE DEVICE DID NOT WORK PROPERLY. IT IS BELIEVED THAT THE DISPOSABLE LOOPS ARE AT FAULT. THERE MAY BE MORE THAN ONE LOT INVOLVED. OLYMPUS WAS INFORMED.

  Patient problems: Insufficient Information

  MAUDE report 12810636 ↗
• MalfunctionSep 9, 2019Break; Break

  THE SERVICE WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) LOOP BROKE INSIDE A PATIENT. THEY WERE ABLE TO RETRIEVE THE LOOP PIECES. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8978284 ↗