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

Lot Number 590996

Device Problems Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Investigation of this event is currently in process.A followup report will be submitted when additional information becoavmes ailable.

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
• Type of Device: 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
• MDR Text Key: 335494077
• Report Number: 1651395-2024-00008
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 590996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1