Olympus WA22738SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaRoller roller, long, 24 Fr., 12°-30°, ESG TURis · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761085417), received between Jul 31, 2023 and Jul 31, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT HER OLYMPUS HF PLASMA ROLLER EXPERIENCED AN OUT OF BOX FAILURE. ACCORDING TO THE INITIAL REPORTER, THE DISTAL END OF THE DEVICE BROKE OFF INSIDE THE PATIENT¿S BLADDER. REPORTEDLY, THE SEPARATED PORTION WAS SUCCESSFULLY REMOVED WITH NO PATIENT HARM. ADDITIONAL DETAILS RELATING TO HOW THE PROCEDURE WAS COMPLETED AND WHETHER THE DEVICE WILL BE RETURNED HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17424507 ↗
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- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.