Olympus WA22607SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaLoop loop, large, 24 Fr., 12°-30°, PK TURis · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761085165), received between Apr 11, 2023 and Sep 10, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Melted1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE HAD A SMALL PIECE OF BROWN PAPER OR SOMETHING SIMILAR IN AN UNOPENED AND UNUSED PACKAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE BEFORE AN "UNSPECIFIED" PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016283 ↗MalfunctionAug 12, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THE HF-RESECTION ELECTRODE "PLASMALOOP" WAS FOUND ON THE UROLOGY CART WITH A SMALL PIECE OF BROWN PAPER OR SOMETHING SIMILAR. THE ITEM WAS NOT OPENED OR USED PRIOR AND THIS MALFUNCTION WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784388 ↗MalfunctionApr 11, 2023Melted; Melted
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A PROCEDURE, THE HF-RESECTION ELECTRODE PLASMA LOOP WAS NOT WORKING PROPERLY. THE LOOP FAILED; THE LARGE RED LOOP LIGHT KEPT BLINKING TO CHECK THE FLUIDS. THIS WAS ONE PIECE FROM THE LOT. THE CUSTOMER SWITCHED OUT THE LOOP AND FINISHED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THAT THE WIRE AT THE DISTAL END OF THE DEVICE WAS MELTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE MELTED DISTAL END WIRE NOTED AT ESTIMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16718374 ↗
Other Electrode, Electrosurgical, Active, Urological devices
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- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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