MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO - PENTAX VALVE KIT; VALVE AND CONNECTOR KIT

Model Number	100315
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has requested the device subject of the reported event be returned for evaluation.Investigation of this event is currently in process and a follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the water jet connector of their pentax valve kit was spraying water when in use and was also dripping water when not in use.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device subject of the reported event is not available to be returned for evaluation.Without the return of the device, a root cause cannot be determined.No additional issues have been reported.

• Brand Name: DEFENDO - PENTAX VALVE KIT
• Common Device Name: VALVE AND CONNECTOR 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: 17325560
• Report Number: 1651395-2023-00017
• Device Sequence Number: 12139902
• Product Code: ODC
• UDI-Device Identifier: 00677964055911
• UDI-Public: 00677964055911
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 07/14/2023

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: 100315
• Device Lot Number: 574337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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