MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO SINGLE USE VALVE KIT

Model Number	100322
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the connection port between the endoscope and water jet pump had a "crack" subsequently causing water to leak out onto the floor.No report of injury.
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris made multiple attempts to obtain information regarding the reported event; however, the user facility and distributor were unable to provide additional information.The defendo single use valve kit subject of the reported event was not returned for evaluation.Without the evaluation of the device, a root cause cannot be determined.A complaint review was performed and confirmed the event to be isolated for the subject lot.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: DEFENDO SINGLE USE VALVE KIT
• Common Device Name: VALVE KIT
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC.; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 21117820
• Report Number: 1651395-2025-00002
• Device Sequence Number: 12932346
• Product Code: ODC
• UDI-Device Identifier: 00677964092992
• UDI-Public: (01)00677964092992(17)270222(10)61870
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 100322
• Device Lot Number: (10)61870
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown