DSD Edge Endoscope Reprocessing System DSD Edge 120VRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00677964046674), received between Sep 28, 2016 and Aug 5, 2026 — classified as 16 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K092387); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147441 ↗
• MalfunctionMay 28, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM AND ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318982 ↗
• MalfunctionMar 13, 2026Smoking

  THE USER FACILITY REPORTED THAT THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM WAS SMOKING AND EMITTING A "BURNING SMELL". NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597492 ↗
• MalfunctionJun 27, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A WATER LEAK IN THE ROOM WITH THEIR TWO DSD EDGE ENDOSCOPE REPROCESSING SYSTEMS. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345834 ↗
• MalfunctionJan 8, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING FOR TWO OF THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEMS FOLLOWING REPORTS OF PATIENTS "BECOMING SICK."

  Patient problems: Insufficient Information

  MAUDE report 21107247 ↗
• MalfunctionOct 18, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A BURN AFTER CONTACTING LIQUID REMAINING IN THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED, AND THE EMPLOYEE CONTINUED WORKING.

  Patient problems: Burn(s)

  MAUDE report 20484871 ↗
• MalfunctionOct 14, 2024Smoking; Smoking

  THE USER FACILITY REPORTED THAT THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM WAS EMITTING SMOKE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441179 ↗
• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT FLUID FROM THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM LEAKED ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669374 ↗
• MalfunctionFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED AN "ACIDIC ODOR" MAKING PERSONNEL DIZZY IN THE SCOPE ROOM WHERE THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM IS LOCATED. IT WAS NOT PROVIDED WHETHER MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 18715047 ↗
• MalfunctionDec 15, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM LEAKED WATER OUT OF THE FOOTPRINT OF THE MACHINE AND ONTO THE FLOOR BELOW. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335588 ↗
• MalfunctionMay 24, 2023Unintended Movement; Unintended Movement

  THE USER FACILITY REPORTED THAT THE LID ON THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER) CONTACTED AN EMPLOYEE'S HEAD SUBSEQUENTLY CAUSING THE EMPLOYEE TO OBTAIN AN INJURY. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Abrasion

  MAUDE report 16999592 ↗
• MalfunctionApr 26, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER AND DISINFECTANT WAS LEAKING FROM THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815122 ↗
• MalfunctionApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY CONTACTED STERIS, REQUESTING FUNCTIONAL TESTING OF THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR.

  Patient problems: Insufficient Information

  MAUDE report 16683984 ↗
• MalfunctionDec 16, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE USER FACILITY NOTIFIED MEDIVATORS TECHNICAL SERVICE OF SEVERAL ISSUES WITH THEIR MEDIVATORS DSD EDGE UNIT, WHICH OCCURRED OVER THE PAST 12 MONTHS. ALL ISSUES WERE REPORTED TO OCCUR DURING THE REPROCESSING OF AN ENDOSCOPE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENTS. FOLLOWING RESOLUTION OF THE REPORTED EVENTS FOR THE FACILITY DSD EDGE, SERIAL NUMBER (B)(4), THE USER FACILITY ADDITIONALLY SUBMITTED THE FOLLOWING USER FACILITY MEDWATCH REPORTS IN NOVEMBER 2021: 2300750000-2021-8012, 2300750000-2021-8013, 2300750000-2021-8014, 2300750000-2021-8015, 2300750000-2021-8016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022650 ↗
• MalfunctionDec 15, 2021No Flow; No Flow

  THE USER FACILITY CONTACTED MEDIVATORS TECHNICAL SERVICE (TSR) AND REPORTED A "NO AIR FLOW" ERROR MESSAGE AND NON-OPERATIONAL COMPRESSOR IN STATION B OF THEIR MEDIVATORS DSD EDGE UNIT. A MEDIVATORS FIELD SERVICE ENGINEER WAS REQUESTED TO BE DISPATCHED TO THE FACILITY TO INVESTIGATE THE REPORTED EVENT. NO PATIENT INVOLVEMENT WAS REPORTED. THE REPORTED DSD EDGE UNIT WAS NOT USED FOR ENDOSCOPE REPROCESSING DURING THE REPORTED EVENT. THE USER FACILITY ADDITIONALLY SUBMITTED USER FACILITY MEDWATCH REPORT (B)(4) ON NOVEMBER 16, 2021, FOLLOWING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014082 ↗
• MalfunctionDec 9, 2021Smoking; Smoking

  A USER FACILITY REPORTED THAT THEIR DISPLAY PANEL ON THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM WAS NOT FUNCTIONING AND DETERGENT APPEARED TO BE LEAKING IN THE UNIT. MEDIVATORS TECHNICAL SERVICE ADVISED THE CUSTOMER TO UNPLUG THE UNIT FROM THE WALL AND DISPATCHED A MEDIVATORS FIELD SERVICE ENGINEER TO GO ON-SITE TO EVALUATE THE UNIT. NO PATIENT OR USER HARM WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968029 ↗
• MalfunctionNov 19, 2021No Flow; No Flow

  THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT # (B)(4) THAT THEIR DSD EDGE AUTOMATED ENDOSCOPY REPROCESSOR (AER) WAS DISPLAYING THE ERROR MESSAGE "NO FLUID FLOW". NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847799 ↗
• MalfunctionSep 24, 2021Smoking; Smoking

  A USER FACILITY REPORT, (B)(4), WAS RECEIVED WHICH ALLEGED SMOKE FROM THE BACK OF THE MEDIVATOR DSD EDGE ENDOSCOPE REPROCESSOR. THE UNIT WAS UNPLUGGED FROM THE WALL AND THE SMOKE WAS CLEARED THROUGH ROOM VENTILATION. THERE WERE NO PATIENTS PRESENT AT THE TIME OF THE EVENT AND NO REPORTS OF HARM OR ADVERSE EVENT WERE RECEIVED. IT WAS NOTED THAT THE GROUND FAULT INTERRUPTER (GFI) HAD BECOME WET THROUGH CONTACT WITH CONDUCTIVE CHEMISTRY FROM THE UNIT. THIS MOST LIKELY LED TO THE REPORTED THERMAL EVENT. A GFI DRIP COVER WAS REQUESTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526613 ↗
• InjuryDec 18, 2019Leak/Splash; Leak/Splash

  THE FACILITY REPORTED A LEAK OF RAPICIDE PA HIGH LEVEL DISINFECTANT FROM THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR CAUSING TWO EMPLOYEES TO BE SENT TO THE EMERGENCY ROOM DUE TO EXPOSURE SYMPTOMS.

  Patient problems: Chemical Exposure

  MAUDE report 9490209 ↗
• InjuryOct 23, 2019Off-Label Use; Off-Label Use

  THE FACILITY REPORTED USING THE INCORRECT HOOKUP WHEN REPROCESSING ENDOSCOPES IN THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT ENDOSCOPES WERE NOT PROPERLY HIGH LEVEL DISINFECTED, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225224 ↗
• InjurySep 26, 2019Fumes or Vapors; Fumes or Vapors

  THE FACILITY REPORTED A STRONG CHEMICAL SMELL FROM THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER) CAUSING OPERATORS TO EXPERIENCE HEADACHES. THERE IS POTENTIAL THAT OPERATORS ARE EXPERIENCING CHEMICAL EXPOSURE SYMPTOMS TO FUMES FROM RAPICIDE PA HIGH-LEVEL DISINFECTANT USED WITH THE AER.

  Patient problems: Chemical Exposure; Headache

  MAUDE report 9124060 ↗
• InjuryApr 1, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING A SERVICE VISIT, A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD NOT BEEN PERFORMING WATER LINE DISINFECTION (WLD) CYCLES FOR THEIR FOUR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSORS (AER). THERE IS POTENTIAL RISK OF CONTAMINATION OF THE ENDOSCOPES REPROCESSED IN THE AERS FROM NOT PERFORMING WLD IN ACCORDANCE WITH THE AER USER MANUAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471059 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDIVATORS RECEIVED MEDWATCH REPORT MW5083990, IN WHICH A FACILITY REPORTED THREE PATIENTS WITH POSITIVE FUNGAL (EXOPHIALA) CULTURES FOLLOWING BRONCHOSCOPY PROCEDURES. THE FACILITY LISTED THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER) ON THE REPORT IN CONNECTION TO THIS EVENT. MEDIVATORS WAS NOT INFORMED OF THIS EVENT DIRECTLY FROM THE FACILITY.

  Patient problems: Fungus; Infection, Indirect

  MAUDE report 8458208 ↗
• InjuryMar 4, 2019Contamination; Improper or Incorrect Procedure or Method; Contamination; Improper or Incorrect Procedure or Method

  A FACILITY REPORTED A BLACK SUBSTANCE APPEARED IN BOTH BASINS OF THEIR DSD EDGE AUTOMATED ENDOSCOPE RE-PROCESSOR (AER) AFTER COMPLETION OF A REPROCESSING CYCLE. THERE IS POTENTIAL FOR PATIENT EXPOSURE TO THE BLACK SUBSTANCE DURING ENDOSCOPY PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387951 ↗
• InjuryJan 29, 2019Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  A FACILITY REPORTED AN INTERNAL COMPONENT OF THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER) ARCED AND BURNED, CAUSING A THERMALLY DAMAGED HOSE INSIDE THE MACHINE TO LEAK DILUTED HIGH-LEVEL DISINFECTANT (HLD) SOLUTION. THE FACILITY REPORTED 6 STAFF MEMBERS SOUGHT MEDICAL ATTENTION FROM INHALATION SYMPTOMS OF NAUSEA, VOMITING, HEADACHES, SORE THROAT AND LIGHT-HEADEDNESS DUE TO THIS INCIDENT.

  Patient problems: Chemical Exposure; Headache; Nausea; Sore Throat; Vomiting

  MAUDE report 8287449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092387. One submission often covers many models, so check the product and lot details in each record.

• Z-2539-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow per