Olympus WA22702SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaLoop loop, medium, 24 Fr., 12°/16°, ESG TURis · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus PlasmaLoop resection electrode is a loop electrode used to cut tissue during prostate and bladder surgery. The reports mostly describe the electrode loop breaking, sometimes on contact with metal inside the body, along with bent or twisted loops, pieces coming loose, and one case where the loop sparked inside the patient. There are 45 reports, no deaths and 3 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 14042761085325), received between Aug 22, 2019 and May 20, 2026 — classified as 3 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
Most reported problems
Device problems
- Break27
- Detachment of Device or Device Component5
- Material Twisted/Bent5
- Sparking3
- Activation Failure1
- Crack1
- Material Split, Cut or Torn1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Material Twisted/Bent
IT WAS REPORTED THE RESECTION ELECTRODE WAS BENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236517 ↗MalfunctionApr 23, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HF-RESECTION ELECTRODE EXHIBITED A BROKEN CAUTERY TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972784 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THE RESECTION ELECTRODE LOOP BROKE AT THE END OF THE ELECTRODE. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866379 ↗MalfunctionApr 6, 2026Sparking
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791314 ↗MalfunctionMar 11, 2026
THE ELECTROCAUTERY LOOP WAS SPARKING WHILE INSIDE THE PATIENT. ONCE REMOVED FROM THE PATIENT, THE LOOP CONTINUED TO SPARK WITHOUT THE FOOT PEDAL BEING DEPRESSED. WE THEN TURNED THE MACHINE OFF. A NEW PLASMA LOOP WAS OPENED. THE SURGEON TOOK THE NEW LOOP AND INSERTED IT INTO THE ORIGINAL WHITE PLASTIC HANDLE OF THE OLD LOOP. THERE WERE NO FURTHER PROBLEMS. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568150 ↗MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23634894 ↗MalfunctionAug 12, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787451 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE BROKE WHEN IT CAME INTO CONTACT WITH METAL INSIDE THE PATIENT'S BODY. THE EVENT OCCURRED WITH THREE DIFFERENT DEVICES DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTRATE. THE BROKEN LOOPS WERE REMOVED FROM THE PATIENT'S BODY. THE CUSTOMER REPORTED THAT THE ISSUE WAS CAUSED BY IMPROPER USE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787408 ↗MalfunctionAug 12, 2025Break; Melted; Break; Melted
IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE BROKE WHEN IT CAME INTO CONTACT WITH METAL INSIDE THE PATIENT'S BODY. THE EVENT OCCURRED WITH THREE DIFFERENT DEVICES DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTRATE. THE BROKEN LOOPS WERE REMOVED FROM THE PATIENT'S BODY. THE CUSTOMER REPORTED THAT THE ISSUE WAS CAUSED BY IMPROPER USE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787364 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22755711 ↗InjuryJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE, THE TIP OF THE PLASMALOOP BROKE OFF INSIDE THE PATIENT'S BODY AND RETRIEVED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331838 ↗InjuryJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE, THE TIP OF THE PLASMALOOP BROKE OFF INSIDE THE PATIENT'S BODY AND RETRIEVED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331806 ↗MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177249 ↗MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177156 ↗MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE HIGH FREQUENCY PLASMA LOOP RESECTION ELECTRODE HAD A LOOP THAT WAS DISCONNECTED. THE EVENT OCCURRED DURING PREPARATION FOR USE IN AN UNSPECIFIED PROCEDURE. THE ISSUE OCCURRED WITH TWO OTHER SIMILAR DEVICES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22149801 ↗MalfunctionSep 23, 2024Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODES WITH HF CABLE EXHIBITED BROKEN WIRE AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20279440 ↗MalfunctionSep 23, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE RESECTION ELECTRODE CUTTING WIRE WAS BROKEN AND SPLIT FROM THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20278055 ↗MalfunctionSep 22, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RESECTION ELECTRODE EXHIBITED BROKEN LOOPS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20276244 ↗MalfunctionSep 20, 2024Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS WIRE AT THE DISTAL END BROKE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20270714 ↗MalfunctionSep 16, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE RESECTION ELECTRODES WITH HIGH FREQUENCY CABLE LOOPS SEEMED TO BE BENT AND WERE FLIMSY WHEN PERFORMING RESECTION. THE LOOP WOULD NOT GO ALL THE WAY INTO THE SHEATH DUE TO THE LOOP BEING BENT. IT WAS REPLACED WITH A SIMILAR PRODUCT. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225026 ↗MalfunctionAug 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODES WITH HF CABLE EXHIBITED CHARRED MARKS ON THE DISTAL TIP AS SIGNS OF USE. THE LOOP AND THE SHAFT WERE ALSO BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20057237 ↗MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED THE RESECTION ELECTRODES WITH HIGH FLOW CABLE HAD A LOOP BREAK OFF AT THE DISTAL END OF THE UNIT. THE ISSUE OCCURRED DURING A THERAPEUTIC AQUABLATION OF PROSTATE PROCEDURE. WHEN THE DOCTOR FINISHED THE AQUABLATION PART AND STARTED THE RESECTION OF THE PROSTATE THE BIPOLAR LOOP BROKE AFTER A FEW STROKES. TWO MORE SIMILAR DEVICES WERE ATTEMPTED AND HAD THE SAME RESULTS. ALL INSTRUMENTS WERE REPLACED AND THE PROCEDURE WAS COMPLETED. THIS WAS AN OUT OF BOX FAILURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711578 ↗MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED THE ELECTRODE LOOP HANDPIECE BROKE OFF AT THE DISTAL END. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19707751 ↗MalfunctionJul 8, 2024Break; Break
IT WAS REPORTED THE ELECTRODE LOOP HANDPIECE BROKE OFF AT THE DISTAL END. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688871 ↗MalfunctionMar 18, 2024Break; Break
IT WAS REPORTED, THE SINGLE-USE ENDOSCOPIC ELECTROSURGICAL ELECTRODE HAD THREE LOOPS SEVERED IN A ROW. THIS WAS AN OUT OF BOX FAILURE THAT OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE. NONE OF THE PRODUCT FELL INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922326 ↗
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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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