MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER; RITTER M9 ULTRACLAVE 115V

Model Number	M9-022
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It could not be confirmed by the user what the sequence of events leading up to the sterilizer falling off the counter were.The user stated no one was in the room at the time the incident occurred.Midmark's investigation determined that the reported event is consistent with a previously identified issue, and that the issue has since been addressed.
Event or Problem Description
Midmark received a complaint that a m9-022 ritter m9 ultraclave fell off of the countertop while running a sterilization cycle.The office reported at the time of the incident no one was in the room to witness what occured or document the sequence of events leading up to the incident.Due to previous reporting of like or similiar sterilizer events, midmark complied to report this instance.

• Brand Name: RITTER
• Common Device Name: RITTER M9 ULTRACLAVE 115V
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: kort fledderjohann ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 24024879
• Report Number: 1523530-2025-00009
• Device Sequence Number: 13045581
• Product Code: FLE
• UDI-Device Identifier: 00841709100062
• UDI-Public: 00841709100062
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M9-022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown