Olympus WA22603SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaLoop loop, large, 24 Fr., 12°/16°, PK TURis · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14042761085134), received between May 14, 2021 and May 22, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- Nov 4, 2022Open, Classified
An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.
Z-0424-2023 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
- Manufacturing, Packaging or Shipping Problem1
- Material Twisted/Bent1
- Melted1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE SHAFT, FORK TUBES, AND LOOP WERE BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25258068 ↗MalfunctionJan 30, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE RESECTION ELECTRODE THAT APPEARED TO HAVE ISSUES WITH THE PACKAGING AND THE CUSTOMER WAS ALSO CONCERNED THAT THE SUBJECT DEVICE WAS NOT STERILE. THE ISSUE WAS FOUND DURING A CYSTOSCOPY WITH FULGURATION AND TRANS-ANAL ENDOSCOPIC RECTAL PROLAPSE SURGERY (TERP), THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223536 ↗MalfunctionOct 27, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 23392782 ↗MalfunctionJul 10, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470597 ↗MalfunctionJun 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE SUBJECT DEVICE WHEN OPENED APPEARED TO HAVE PINHOLES IN THE TRIANGLE SHAPED AREA. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284588 ↗MalfunctionJul 16, 2024Melted; Melted
IT WAS REPORTED, THE ELECTRODE HAD A BURNT TIP. CAUSED BY A WORKING ELEMENT. THE ISSUE, OCCURRED 30 MINUTES INTO RESECTING, DURING A RESECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19747435 ↗MalfunctionMay 14, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE NURSE AT THE USER FACILITY REPORTED, DURING A CYSTOSCOPY TRANSURETHRAL RESECTION OF A BLADDER TUMOR, THE HIGH FREQUENCY RESECTION ELECTRODE "PLASMA LOOP" REPORTEDLY BROKE OFF INSIDE OF A PATIENT'S BLADDER; THE SURGEON RETRIEVED THE BROKEN PIECE. NO DEATH, SERIOUS INJURY OR ADVERSE OUTCOME TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11829099 ↗
Other Electrode, Electrosurgical, Active, Urological devices
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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 WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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