MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; MIDMARK M11-020 ULTRACLAVE

Model Number	M11-020
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical trainer reported while running a sterilization cycle the sterilizer fell off of the countertop onto the floor.The noise created during the incident left a ringing sound in her ears.
Additional Manufacturer Narrative
While running a sterilization cycle the unit fell off the countertop.The noise from the event caused a ringing sound in the clinicians ears.The clinician was evaluated and returned to work.

• Brand Name: MIDMARK
• Common Device Name: MIDMARK M11-020 ULTRACLAVE
• 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 ; 9375268644
• MDR Report Key: 24788838
• Report Number: 1523530-2026-00002
• Device Sequence Number: 8859227
• Product Code: FLE
• UDI-Device Identifier: 00841709100109
• UDI-Public: 00841709100109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K990189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: M11-020
• Device Catalogue Number: M11-020
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown