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

Model Number	100316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A cantel account manager has scheduled a meeting with the user facility to discuss the reported event and proper use of the defendo valves.The investigation for the reported event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure including use of a defendo disposable suction valve, there was too much suction causing the endoscope to suction to the patient's mucous membrane.No report of injury.
Additional Manufacturer Narrative
A medivators account manager visited onsite at the user facility for two days to review the reported event and proper use of the valve.During the visit, the account manager learned that user facility personnel have continued use of the valves and the reported event has not recurred.Additionally, medivators tested 30 samples of current inventory and no issues were noted.The device subject of the event was not returned for evaluation.Without the returned device, a root cause could not be determined.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: 15128619
• Report Number: 1651395-2022-00005
• Device Sequence Number: 17492661
• Product Code: ODC
• UDI-Device Identifier: 00677964055928
• UDI-Public: 00677964055928
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 100316
• Device Lot Number: 527522
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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