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

Model Number	100310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medivators has requested that the customer return samples from the same lot subject of the event for evaluation.A follow-up report will be submitted when additional information becomes available.There have been no other complaints associated with this lot.
Event or Problem Description
The distributor reported that the suction valve from their defendo valves & kits was stuck in the depressed position during a patient procedure.The valve broke as user facility personnel attempted to pull it out causing half of the valve to become stuck in the endoscope.A procedure delay occurred as user facility personnel exchanged the endoscope.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Medivators is pending receipt of samples from the same lot subject of the event for evaluation.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Medivators has sent multiple requests to the distributor to return samples for evaluation.To date, medivators has not received returned samples from the distributor for evaluation.Without return of the device for evaluation, a root cause could not be determined.The device history record for the lot subject of the event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.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: 18159937
• Report Number: 1651395-2023-00019
• Device Sequence Number: 6504382
• Product Code: ODC
• UDI-Device Identifier: 00677964052453
• UDI-Public: 00677964052453
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2023

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: 100310
• Device Catalogue Number: 100310
• Device Lot Number: 582961
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/12/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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