MAUDE Adverse Event Report: MEDIVATORS INC DEFENDO - OLYMPUS VALVE KIT; DEFENDO SINGLE USE VALVE KIT

Lot Number	590996
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure a valve was "stuck" in the scope and could not be actuated.User facility personnel utilized another scope and the procedure was completed successfully.A procedure delay was reported due to exchange of the scopes.No report of injury.
Additional Manufacturer Narrative
Investigation of this event is currently in process.A followup report will be submitted when additional information becoavmes ailable.
Additional Manufacturer Narrative
The user facility returned four (4) unopened/unused valve kits for evaluation.The unopened returned kits were visually inspected, and no issues were noted.The suction valves were functionally tested on a scope to confirm if the reported "sticking" could be duplicated.All four suction valves passed the functional test and performed as designed; no sticking was observed and the reported event could not be duplicated.The valve kit subject of the reported event was not returned for evaluation.Without the return of the subject device, a root cause cannot be determined.The device history record (dhr) was reviewed, and no abnormalities were noted.A complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: DEFENDO - OLYMPUS VALVE KIT
• Common Device Name: DEFENDO SINGLE USE 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: 18715005
• Report Number: 1651395-2024-00008
• Device Sequence Number: 18202486
• Product Code: FDF
• UDI-Device Identifier: 00677964092992
• UDI-Public: 00677964092992
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 02/15/2024

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 Lot Number: 590996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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