USA Elite MLE-28-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925038486), received between Aug 11, 2022 and Aug 11, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS TWO SIMILAR EVENTS: DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) USING A CUTTING LOOP, THE CUTTING LOOP WIRE BECAME DISLODGED FROM THE SHAFT OF ELECTRODE (INSIDE THE PATIENT). THE SURGEON USED IRRIGATION TO FLUSH THE LOOP OUT OF THE PATIENT. THE LOOP DID NOT COME INTO CONTACT WITH ANY OTHER INSTRUMENTS TO THE SURGEONS¿ KNOWLEDGE. NO FURTHER CONSEQUENCES TO THIS PATIENT HAVE BEEN REPORTED. CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS THE FIRST EVENT USING A SINGLE USE CUTTING LOOP. CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS THE SECOND EVENT USING A SINGLE USE CUTTING LOOP.

  Patient problems: Foreign Body In Patient

  MAUDE report 15210530 ↗
• InjuryAug 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS TWO SIMILAR EVENTS: DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) USING A CUTTING LOOP, THE CUTTING LOOP WIRE BECAME DISLODGED FROM THE SHAFT OF ELECTRODE (INSIDE THE PATIENT). THE SURGEON USED IRRIGATION TO FLUSH THE LOOP OUT OF THE PATIENT. THE LOOP DID NOT COME INTO CONTACT WITH ANY OTHER INSTRUMENTS TO THE SURGEONS¿ KNOWLEDGE. NO FURTHER CONSEQUENCES TO THIS PATIENT HAVE BEEN REPORTED. CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS THE FIRST EVENT USING A SINGLE USE CUTTING LOOP. CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS THE SECOND EVENT USING A SINGLE USE CUTTING LOOP.

  Patient problems: Foreign Body In Patient

  MAUDE report 15210526 ↗

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-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• 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-0568-2024 · Oct 2, 2023 · Open, Classified
  ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF M
• 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