Olympus WA22306DRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus electrosurgical resection electrode has 117 adverse event reports on file. Many describe the loop wire breaking, bending or fragmenting during set-up or use, and a few mention pieces left in the patient. The reports include no deaths and 21 injuries. There is 1 recall, still open since June 2023, over the loop wire breaking after contact with metal objects such as other endoscopic equipment, implants or stents, which can let fragments fall inside the patient.
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
- 117
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 14042761051689), received between May 15, 2018 and May 14, 2026 — classified as 21 injuries, 96 malfunctions.
The most frequently reported specific device problem is “Break” (55 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 8, 2023Open, Classified
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
Z-2413-2023 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Break55
- Material Twisted/Bent22
- Fracture19
- Material Fragmentation19
- Mechanical Problem18
- Material Deformation12
- Detachment of Device or Device Component8
- Melted8
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient6
- Device Embedded In Tissue or Plaque4
- Internal Organ Perforation3
- Asystole1
- Burn(s)1
- Ecchymosis1
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Device Damaged Prior to Receipt by User
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166956 ↗MalfunctionMay 4, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED THE DISTAL END OF THE PRODUCT WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075900 ↗MalfunctionMay 1, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED THE THE DISTAL END OF THE PRODUCT WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059644 ↗MalfunctionApr 24, 2026Material Deformation
IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS DEFORMED. THE DISTAL END WAS BENT. THE ISSUE OCCURRED DURING SET UP FOR A THERAPEUTIC TUR PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984014 ↗MalfunctionApr 23, 2026Material Deformation
IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD A DISTORTED DISTAL END OF THE ELECTRODE BEFORE USE. THIS MALFUNCTION OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24969070 ↗MalfunctionApr 22, 2026Material Twisted/Bent
IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960972 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THE HF-RESECTION ELECTRODE INSERTION SECTION WAS BROKEN WHEN UNPACKED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960920 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THE RESECTION ELECTRODE APPEARED BENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24947468 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED THE HF-RESECTION DISTAL END ELECTRODE WAS BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931704 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THE RESECTION ELECTRODE ELECTRIC CUTTING LOOP HAD BROKE OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865121 ↗MalfunctionApr 7, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE HAD A BENT DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809152 ↗MalfunctionApr 3, 2026Material Deformation
IT WAS REPORTED THE RESECTION ELECTRODE HAD BROKE AT THE MOMENT OF OUTPUT. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780652 ↗MalfunctionMar 16, 2026Degraded
IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP'S WIDTH OF THE DISTAL END BECAME NARROW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606276 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THE RESECTION ELECTRODE LOOP PORTION OF THE LOOP ELECTRODE WAS DAMAGED. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583896 ↗MalfunctionFeb 18, 2026Material Deformation
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378797 ↗MalfunctionFeb 13, 2026Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24339343 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THE HF-RESECTION ELECTRODE, LOOP BROKE DURING THE RESECTION. THE ISSUE WAS FOUND DURING A THERAPEUTIC 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 24318211 ↗MalfunctionFeb 4, 2026Material Twisted/Bent
IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD A BENT ELECTRODE AT THE DISTAL END. THE MALFUNCTION WAS NOTICED DURING INSPECTION FOR USE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261677 ↗MalfunctionJan 5, 2026Material Integrity Problem
IT WAS REPORTED THAT THE RESECTION ELECTRODE LOOP WAS ATTACHED BACKWARDS. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23970198 ↗MalfunctionDec 16, 2025Melted; Melted
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820552 ↗MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555076 ↗MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE RESECTION ELECTRODE WAS BENT DURING UNPACKING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23503628 ↗MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE LOOP WAS BENT ON THE RESECTION ELECTRODE. THE UNSPECIFIC PROCEDURE WAS COMPLETED BY REPLACING IT WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496848 ↗MalfunctionNov 5, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479979 ↗MalfunctionNov 4, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION PROVIDED BY THE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468426 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.