MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO DISPOSABLE BIOPSY VALVE

Model Number	100302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report that their defendo biopsy valve leaked.No report of injury or procedure delay.
Additional Manufacturer Narrative
The user facility returned the defendo biopsy valve for evaluation.The evaluation determined that the biopsy lid slit was not resealing properly allowing fluid to leak.The exact cause of the event could not be determined.The device history record (dhr) was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.We will continue to monitor to ensure the product continues to perform as expected.

• Brand Name: DEFENDO DISPOSABLE BIOPSY VALVE
• Common Device Name: DEFENDO DISPOSABLE BIOPSY VALVE
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4402597401
• MDR Report Key: 21954137
• Report Number: 1651395-2025-00009
• Device Sequence Number: 18232427
• Product Code: ODC
• UDI-Device Identifier: 00677964060267
• UDI-Public: (01)00677964060267(17)271217(10)648156
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090851
• 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): 05/02/2025

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: 100302
• Device Catalogue Number: 100302
• Device Lot Number: (10)648156
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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