Advantage Plus Pass-Thru 1-2-610.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00677964095832), received between Mar 8, 2022 and May 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K172677); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT DISINFECTANT LEAKED FROM THEIR ADVANTAGE PLUS PASS-THRU SUBSEQUENTLY CAUSING TWO EMPLOYEES TO EXPERIENCE EYE IRRITATION. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (EYE IRRIGATION).

  Patient problems: Eye Irritation

  MAUDE report 25305670 ↗
• MalfunctionMar 18, 2026Device Reprocessing Problem

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS PASS-THRU WAS NOT WORKING PROPERLY. BECAUSE THE FACILITY HAD NO OTHER AVAILABLE METHODS OF REPROCESSING DEVICES, PROCEDURES WERE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627771 ↗
• MalfunctionMar 18, 2026Computer Operating System Problem

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS PASS-THRU WAS NOT WORKING PROPERLY. BECAUSE THE FACILITY HAD NO OTHER AVAILABLE METHODS OF REPROCESSING DEVICES, PROCEDURES WERE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627765 ↗
• MalfunctionNov 7, 2025Filtration Problem; Filtration Problem

  THE USER FACILITY REPORTED THAT THE FILTERS OF TWO ADVANTAGE PLUS PASS-THRU UNITS REQUIRE REPLACEMENT EVERY 2-3 DAYS. AS A RESULT, MULTIPLE PATIENT PROCEDURES WERE POSTPONED AS THE USER FACILITY DID NOT HAVE ALTERNATIVE REPROCESSING METHODS AVAILABLE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498736 ↗
• MalfunctionFeb 7, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE FILTERS OF TWO ADVANTAGE PLUS PASS-THRU UNITS CLOGGED AND GAVE A WATERFLOW ALARM. AS A RESULT, MULTIPLE PATIENT PROCEDURES WERE POSTPONED AS THE USER FACILITY DID NOT HAVE ALTERNATIVE REPROCESSING METHODS AVAILABLE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337340 ↗
• MalfunctionDec 27, 2024Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS PASS-THRU ALARMED FOR AN INTERNAL FLUID LEAK ERROR IN THE RIGHT BASIN. WHEN THE EMPLOYEE ACKNOWLEDGED THE ALARM, THE LEFT BASIN DOOR OPENED AND "SPRAYED" DISINFECTANT INTO THE ROOM SUBSEQUENTLY CONTACTING AN EMPLOYEE'S EYES. THE EMPLOYEE SOUGHT TREATMENT AT THE FACILITY'S EMERGENCY ROOM.

  Patient problems: Pain

  MAUDE report 21025582 ↗
• MalfunctionJul 11, 2024Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS PASS-THRU DOOR CLOSED AND CONTACTED AN OPERATOR'S HAND RESULTING IN A BUMP AND SLIGHT BRUISE ON THE BACK OF THEIR HAND. NO MEDICAL TREATMENT SOUGHT OR ADMINISTERED.

  Patient problems: Bruise/Contusion

  MAUDE report 19726552 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR ADVANTAGE PLUS PASS THRU ENDOSCOPE REPROCESSING SYSTEM INTO THE FLOOR BELOW. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990170 ↗
• MalfunctionOct 6, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS PASS-THRU DOOR OPENED WHILE IN-CYCLE, SPRAYING LIQUID ALL OVER THE ROOM. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550914 ↗
• MalfunctionMar 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO BFARM THAT AS AN EMPLOYEE WAS UNLOADING THEIR ADVANTAGE PLUS PASS-THRU ENDOSCOPE REPROCESSING SYSTEM THE DOOR CONTACTED THE EMPLOYEES ARM RESULTING IN TWO BRUISES. THE EMPLOYEE RETURNED TO WORK.

  Patient problems: Bruise/Contusion

  MAUDE report 13698353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172677. One submission often covers many models, so check the product and lot details in each record.

• Z-0617-2024 · Nov 13, 2023 · Open, Classified
  Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-01