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Olympus WA22751SRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaRoller roller, 24 Fr., 12°-30°, ESG TURis · Class 2

Adverse event reports
8
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14042761085486), received between Apr 14, 2021 and Apr 30, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break6
  • Detachment of Device or Device Component3
  • Thermal Decomposition of Device2
  • Material Fragmentation1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

Recent adverse event reports

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

  • MalfunctionApr 30, 2026Material Twisted/Bent

    IT WAS REPORTED THE RESECTION ELECTRODE HAD A BENT FORK TUBE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25052819 ↗
  • MalfunctionAug 18, 2025Break; Break

    IT WAS REPORTED THE SUBJECT DEVICE BROKE DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22826354 ↗
  • InjuryNov 7, 2024Break; Thermal Decomposition of Device; Detachment of Device or Device Component; Break; Thermal Decomposition of Device; Detachment of Device or Device Component

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20635252 ↗
  • InjuryNov 7, 2024Break; Thermal Decomposition of Device; Detachment of Device or Device Component; Break; Thermal Decomposition of Device; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BALL AT THE TIP OF THE RESECTION ELECTRODE DEVICE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN DESCRIBED THE EVENT AS IT "BURNED OFF." THE EVENT OCCURRED AFTER APPROXIMATELY 20 MINUTES OF USE DURING A THERAPEUTIC PROSTATE VAPORIZATION. THE BALL WAS RETRIEVED INTACT. THE PROCEDURE LASTED FOR APPROXIMATELY 70 MINUTES, WITH AN ADDITIONAL 1-2 MINUTES IN RETRIEVING THE BROKEN PIECE AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20632381 ↗
  • InjuryJun 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THE LOOP BROKE INSIDE PATIENT DURING A THERAPEUTIC PROSTATE RESECTION PROCEDURE. SURGEON WAS ABLE TO RETRIEVE THE PIECE SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19553652 ↗
  • InjuryJan 3, 2024Break; Break

    A OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A UNKNOWN THERAPEUTIC PROCEDURE THE TIP OF HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, ESG TURIS BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE AS RECOVERED AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18434300 ↗
  • InjuryJan 3, 2024Break; Break

    A OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A UNKNOWN THERAPEUTIC PROCEDURE THE TIP OF HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, ESG TURIS BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE AS RECOVERED AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18434272 ↗
  • MalfunctionApr 14, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED TO OLYMPUS THAT THE ROLLER BALL FELL OFF THE ROLLER DURING A PROCEDURE. IT WAS NOT DETERMINED IF THE BALL FELL INTO THE PATIENT OR ON THE GROUND. THE PATIENT HAD X-RAYS, HOWEVER, THE ROLLER BALL WAS NOT LOCATED IN THE PATIENT. THE FACILITY WILL MONITOR THE PATIENT. NO PATIENT HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11665110 ↗

Other Electrode, Electrosurgical, Active, Urological devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.