USA Elite MLE-24-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821925036413), received between Apr 2, 2020 and Dec 14, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K890328); they may or may not involve this specific model.

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.

Recalls naming this device

1. Oct 2, 2023Open, Classified

   Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

   Z-0568-2024 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Fracture; Fracture

  THE CUSTOMER REPORTED TO OLYMPUS THE CUTTING LOOP WIRE LOOP WAS BREAKING THROUGH THE INSULATION BEFORE BREAKING ALTOGETHER. THE ISSUE WAS FOUND DURING AN UNIDENTIFIED PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, MISHANDLING OF THE DEVICE LEADING TO THE BREAK WAS FOUND WHICH CONSTITUTES A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326290 ↗
• MalfunctionDec 21, 2022Connection Problem; Connection Problem

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A CUTTING LOOP, THE CUTTING LOOP WOULD NOT MEET CONNECTION TO CORD IN WORKING ELEMENT. THE USER HAD TO OPEN ANOTHER. THERE WAS NO RISK TO STAFF OR PATIENT. THE PROCEDURE WAS PROLONGED LONG ENOUGH TO GET NEW EQUIPMENT WITH NO FURTHER CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028016 ↗
• MalfunctionDec 21, 2022Connection Problem; Connection Problem

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A CUTTING LOOP, THE CUTTING LOOP WOULD NOT MEET CONNECTION TO CORD IN WORKING ELEMENT. THE USER HAD TO OPEN ANOTHER. THERE WAS NO RISK TO STAFF OR PATIENT. THE PROCEDURE WAS PROLONGED LONG ENOUGH TO GET NEW EQUIPMENT WITH NO FURTHER CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16027653 ↗
• MalfunctionJul 22, 2022Sparking; Sparking

  AS REPORTED, DURING A HYSTEROSCOPIC RESECTION THERAPEUTIC PROCEDURE, UPON ACTIVATION IN THE PATIENT, COULD HEAR SPARKING FROM INSIDE THE PATIENT AND COULD SMELL BURNING OF PLASTIC. THE ELECTRODE WAS IMMEDIATELY REMOVED AND REPLACED. THE CASE WAS SUCCESSFULLY COMPLETED WITH A NEW ELECTRODE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089876 ↗
• MalfunctionApr 22, 2021Arcing of Electrodes; Defective Device; Arcing of Electrodes; Defective Device

  QUANTITY OF 3 ELECTRODES WITH THE SAME MODEL AND LOT NUMBER WERE USED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THE FIRST TWO (2 FAILED) AND THE THIRD (3RD) ONE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THE ELECTRODES WERE REPORTED TO BE DEFECTIVE (ARCED). THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS COMPLAINT IS RELATED TO REPORTS PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711753 ↗
• MalfunctionApr 22, 2021Arcing of Electrodes; Defective Device; Arcing of Electrodes; Defective Device

  QUANTITY OF 3 ELECTRODES WITH THE SAME MODEL AND LOT NUMBER WERE USED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THE FIRST TWO (2 FAILED) AND THE THIRD (3RD) ONE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THE ELECTRODES WERE REPORTED TO BE DEFECTIVE (ARCED). THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS COMPLAINT IS RELATED TO REPORT PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711748 ↗
• MalfunctionApr 22, 2021Arcing of Electrodes; Defective Device; Arcing of Electrodes; Defective Device

  QUANTITY OF 3 ELECTRODES WITH THE SAME MODEL AND LOT NUMBER WERE USED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THE FIRST TWO (2 FAILED) AND THE THIRD (3RD) ONE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THE ELECTRODES WERE REPORTED TO BE DEFECTIVE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS COMPLAINT IS RELATED TO REPORTS PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711689 ↗
• MalfunctionFeb 26, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE 4 ELECTRODES ARCED WHILE USING IN THE PATIENT. THERE WERE NO FURTHER DETAILS PROVIDED REGARDING THE EVENT. THERE WAS NO PATIENT INFECTION, INJURY OR HARM REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385507 ↗
• MalfunctionApr 2, 2020Component Missing

  DURING A HYSTEROSCOPY/MYOMECTOMY, A RIGHT ANGLE CUTTING LOOP ELECTRODE WAS USED. THE CUTTING LOOP DISAPPEARED AS IF IT DISINTEGRATED OR BURNED OFF. AT THE TIME IT WAS BEING USED AT 220 CUT, 100 COAG. BOTH THE UTERUS AND SPECIMEN WERE SEARCHED FOR ANY PARTS. PHYSICIAN WAS CONFIDENT THAT NOTHING WAS LEFT BEHIND. DEVICE WAS GIVEN TO MATERIAL'S MANAGEMENT FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9915849 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K890328. One submission often covers many models, so check the product and lot details in each record.

• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-2720-2026 · May 5, 2026 · Open, Classified
  Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
• Z-2140-2025 · Jun 18, 2025 · Open, Classified
  Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the work
• Z-2139-2025 · Jun 18, 2025 · Open, Classified
  Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some
• Z-1952-2018 · Apr 17, 2018 · Terminated
  Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs t