MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO DISPOSABLE SUCTION VALVE

Model Number	100315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during patient procedures which included use of the defendo - pentax valve kit, the suction valve sticks and may remain in the on position resulting in suction of the mucosal and a procedure delay.No report of injury.
Additional Manufacturer Narrative
The customer has not returned any product for investigation.Without a returned device, the root cause cannot be determined.The device history record of the lots of the reported event were reviewed and no issues were noted.Additionally, medivators tested 100 samples of current inventory and no issues were noted.No additional issues have been reported.

• Brand Name: DEFENDO DISPOSABLE SUCTION VALVE
• Common Device Name: SUCTION VALVE
• 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: 15481575
• Report Number: 1651395-2022-00015
• Device Sequence Number: 6952600
• Product Code: ODC
• UDI-Device Identifier: 00677964055911
• UDI-Public: 00677964055911
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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): 09/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100315
• Device Lot Number: 539252, 517199, 542719
• 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: 08/25/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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