MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO - OLYMPUS 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	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defendo - olympus valve kit subject of the reported event was not returned for evaluation.Without the return of the device a root cause cannot be determined.The device history record (dhr) were reviewed, and no abnormalities were noted; the lot was manufactured to specifications.The instructions for use states, "push down on the single use air/water valve, twisting slightly back and forth, until the valve engages on the air/water port.Prior to the procedure, depress single use air/water valve to prime air/water channel.Discard the single use air/water valve after each procedure prior to reprocessing the endoscope." a complaint review was conducted and determined this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure which included use of the defendo - olympus valve kit, the air/water valve becomes "jammed" after repeated actuations causing water to escape from the endoscope control head.No report of injury.

• Brand Name: DEFENDO - OLYMPUS VALVE KIT
• Common Device Name: DEFENDO - OLYMPUS 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: 18374800
• Report Number: 1651395-2023-00067
• Device Sequence Number: 7722728
• Product Code: ODC
• UDI-Device Identifier: 00677964092992
• UDI-Public: 00677964092992
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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: 100322
• Device Catalogue Number: 100322
• Device Lot Number: 579425
• 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: 09/13/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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