MAUDE Adverse Event Report: MEDIVATORS INC. ENDO SMARTCAP; ENDO SMARTCAP TUBING DEVICE

Model Number	100164CO2EXT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from the scope air/water valve during use of multiple of their endo smartcap tubing devices.No report of injury.
Additional Manufacturer Narrative
Investigation of the reported event is in process.The devices are being returned for evaluation.A follow-up report will be submitted once additional information becomes available.

• Brand Name: ENDO SMARTCAP
• Common Device Name: ENDO SMARTCAP TUBING DEVICE
• 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: 24401777
• Report Number: 1651395-2026-00004
• Device Sequence Number: 9859091
• Product Code: FAJ
• UDI-Device Identifier: 00677964111075
• UDI-Public: (01)00677964111075(17)280814(10)668669
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K093665
• 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): 02/20/2026

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: 100164CO2EXT
• Device Lot Number: (10)668669
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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