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Olympus WA22706SRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaLoop loop, medium, 24 Fr., 12°-30°, ESG TURis · Class 2

Quick summary

This Olympus PlasmaLoop is a electrosurgical resection electrode used in urology and hysteroscopy procedures to cut tissue. Most of the 46 reports describe the loop breaking during surgery, sometimes leaving the surgeon to finish with another instrument, along with bent or deformed shafts and pieces detaching;6 reports involved an injury. No deaths were reported and 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
46
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 14042761085356), received between Nov 10, 2020 and May 29, 2026 — classified as 6 injuries, 40 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

Nov 2023: 2 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 2 reportsNov 2025: 2 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 4 reportsMay 2026: 5 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break27
  • Material Disintegration6
  • Detachment of Device or Device Component4
  • Material Twisted/Bent3
  • Material Deformation2
  • Melted2
  • Thermal Decomposition of Device2
  • Defective Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions32
  • No Consequences Or Impact To Patient8
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
  • Device Embedded In Tissue or Plaque1
  • Laceration(s)1
  • Unspecified Kidney or Urinary Problem1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 29, 2026Material Twisted/Bent

    THE CUSTOMER RETURNED THE HF-RESECTION ELECTRODE "PLASMALOOP TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT THE PLASMA LOOP AND SHAFT WERE BENT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25333542 ↗
  • MalfunctionMay 25, 2026Material Twisted/Bent

    IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS SEVERELY BENT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25273216 ↗
  • MalfunctionMay 20, 2026Break

    IT WAS REPORTED THE RESECTION ELECTRODE LOOP HAD BROKE. THE ISSUE WAS DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE AND WAS COMPLETED USING A SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25235709 ↗
  • MalfunctionMay 15, 2026Fracture

    IT WAS REPORTED THE HF-RESECTION ELECTRODE PLASMALOOP BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC HISTEROSCOPIA PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25185864 ↗
  • MalfunctionMay 14, 2026Break

    IT WAS REPORTED THE RESECTION ELECTRODE PLASMA LOOP, THE LOOP HANDLE BROKE OFF DURING A SURGERY, HOWEVER, THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25177443 ↗
  • MalfunctionApr 15, 2026Break

    IT WAS REPORTED THE RESECTION ELECTRODE PLASMA LOOP BROKE DURING THE PROCEDURE. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24887019 ↗
  • MalfunctionApr 14, 2026Break

    IT WAS REPORTED THE HF-RESECTION ELECTRODE "PLASMALOOP" HAD THE LOOPS BREAK DURING THE THERAPEUTIC PROCEDURE REQUIRING THE OPEN OF A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24877021 ↗
  • MalfunctionApr 11, 2026Break

    IT WAS REPORTED THE RESECTION ELECTRODE LOOPS HAD BROKE. THE ISSUE WAS FOUND DURING A THERAPEUTIC REMOTE TERMINAL UNIT (RTU) AND COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24846508 ↗
  • MalfunctionApr 8, 2026Break; Melted

    IT WAS REPORTED THE RESECTION ELECTRODE THAT THE TWO LOOPS HAD MELTED (BROKEN) DURING THE RAPID UREASE TEST 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 24819651 ↗
  • MalfunctionMar 13, 2026Material Twisted/Bent

    IT WAS REPORTED THE HF-RESECTION ELECTRODE PLASMALOOP WAS BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24591219 ↗
  • MalfunctionDec 22, 2025Break; Break

    IT WAS REPORTED THE HF-RESECTION ELECTRODE "PLASMALOOP" HAD A WIRE OF TWO BIPOLAR LOOP ELECTRODES BREAK. THE PATIENT HAD BRACHYTHERAPY METAL SEEDS IMPLANTED IN HIS PROSTATE, WHICH CAN DAMAGE THE LOOP ELECTRODE. THERE WERE NO REPORTS OF PATIENT HARM/INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23865949 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THE RESECTION ELECTRODE (PLASMA LOOP) HAD THE WIRE OF TWO BIPOLAR LOOP ELECTRODES BROKE DURING A RENAL DENERVATION (RTU HBP) 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 23576497 ↗
  • MalfunctionNov 13, 2025Melted; Melted

    IT WAS REPORTED THE SUBJECT DEVICE HANDLE MELTED DURING A PROSTATE RESECTION THERAPEUTIC SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23547911 ↗
  • MalfunctionOct 29, 2025Break; Break

    IT WAS REPORTED THE SUBJECT DEVICE HAD AN ERROR MESSAGE STATING "INSUFFICIENT CONDUCTIVITY" DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH A NEW ELECTRODE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURIES.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 23413702 ↗
  • MalfunctionOct 29, 2025Break; Break

    IT WAS REPORTED THE SUBJECT DEVICE HAD AN ERROR MESSAGE STATING "INSUFFICIENT CONDUCTIVITY" DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH A NEW ELECTRODE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 23413653 ↗
  • MalfunctionSep 12, 2025Material Deformation; Material Deformation

    DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED THE CUTTING LOOP WAS BENT DOWN AND HAD CHARRED MARKS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23039632 ↗
  • MalfunctionJul 29, 2025Sparking; Sparking

    THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22646810 ↗
  • MalfunctionMay 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF A PROSTATE THERAPEUTIC PROCEDURE, THE HF-RESECTION ELECTRODE LOOP HAD HUMAN HAIR IN STERILE PACKAGING STUCK TO STICKER LABEL ON THE CORD. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21961903 ↗
  • MalfunctionMar 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

    THERE WAS RUPTURE OF THE LOOP AND INTERRUPTION OF THE ELECTRIC CURRENT. THE FIRST LOOP BURNED SOON AFTER THE FIRST PEDAL ACTIVATION ALREADY INSIDE THE PATIENT'S URETHRA. THE SECOND ONE THE PHYSICIAN TESTED PRIOR TO USE BEFORE CONTACTING THE PATIENT (OUTSIDE PATIENT), WHERE IT BURNED AND GOT DARK WITH A BURNING SMELL. THE PROCEDURE TIME INCREASED ABOUT 15 MINUTES, DUE TO THE NECESSITY OF CHANGING THE DEVICE PLUS THE EQUIPMENT. THE EVENT OCCURRED DURING A PROSTATE HYPERPLASIA PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21619463 ↗
  • MalfunctionMar 13, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

    THERE WAS RUPTURE OF THE LOOP AND INTERRUPTION OF THE ELECTRIC CURRENT. THE FIRST LOOP BURNED SOON AFTER THE FIRST PEDAL ACTIVATION ALREADY INSIDE THE PATIENT'S URETHRA. THE SECOND ONE, THE PHYSICIAN TESTED PRIOR TO USE BEFORE CONTACTING THE PATIENT (OUTSIDE PATIENT), WHERE IT BURNED AND GOT DARK WITH A BURNING SMELL. THE PROCEDURE TIME INCREASED ABOUT 15 MINUTES, DUE TO THE NECESSITY OF CHANGING THE DEVICE PLUS THE EQUIPMENT. THE EVENT OCCURRED DURING A PROSTATE HYPERPLASIA PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21596288 ↗
  • MalfunctionMar 7, 2025Material Deformation; Material Deformation

    DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED THE CUTTING LOOP WAS BENT DOWN AND HAD CHARRED MARKS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21554217 ↗
  • MalfunctionJan 28, 2025Defective Device; Defective Device

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21260627 ↗
  • MalfunctionSep 11, 2024Break; Break

    IT WAS REPORTED THE LOOP WAS ALREADY BROKEN UPON OPENING THE PACKAGING OF THE HF-RESECTION ELECTRODE. HERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20191556 ↗
  • MalfunctionSep 3, 2024Break; Break

    IT WAS REPORTED THE SINGLE USE RESECTION ELECTRODE BECAME DAMAGED AFTER ABOUT 10-MINUTES OF USE. THE ISSUE OCCURRED DURING AN UNSPECIFIED ENDOSCOPIC RESECTION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE FROM THE SAME BATCH. THERE WERE NO REPORTS OF DELAYS OR OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20124466 ↗
  • MalfunctionMar 26, 2024Break; Break

    IT WAS REPORTED THAT THE PLASMALOOP TIP BROKE OFF INTO THE BLADDER AND WAS RETRIEVED DURING ENERGIZING. IT OCCURRED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18979309 ↗

Other Electrode, Electrosurgical, Active, Urological devices

All Electrode, Electrosurgical, Active, Urological devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.