MAUDE Adverse Event Report: MEDIVATORS INC DEFENDO AIR/WATER/SUCTION AND BIOPSY VALVE

Model Number	100305
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report to ansm that they are experiencing "problems with the operating channel valve (black cap): on several occasions the sample got stuck at the opening of this cap with the suction valve (device with a red dot): did not return to its initial position after aspiration during the examination." no report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the device a root cause cannot be determined.The device history record (dhr) was reviewed and confirmed the subject lot was manufactured to specifications; no abnormalities were noted.A complaint review confirmed the reported event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: DEFENDO AIR/WATER/SUCTION AND BIOPSY VALVE
• Common Device Name: DEFENDO AIR/WATER/SUCTION AND BIOPSY 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: 19719770
• Report Number: 1651395-2024-00018
• Device Sequence Number: 8130421
• Product Code: ODC
• UDI-Device Identifier: 00677964060250
• UDI-Public: (01)00677964060250(11)240126(17)270125(10)614992
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/11/2024

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 Model Number: 100305
• Device Catalogue Number: 100305
• Device Lot Number: 614992
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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