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

Model Number	100164CO2EXT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process.A follow-up report will be submitted once additional information becomes available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that water was spraying from the air/water valve during a procedure which included use of the endo smartcap tubing.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.The unopened and unused units of the subject lot were returned for evaluation.After further evaluation, all of the returned devices performed as designed, there were no abnormalities with the function or operation of the devices.The cause of the reported event could not be determined.The endo smartcap tubing instructions for use states, "always inspect the gi endoscopes o-rings and gaskets (air/water button, endoscope connection, etc.) for damage.Damaged components can result in less than optimal performance of endo smartcap tubing".The device history record for the subject lot was reviewed and confirmed the lot was manufactured according to specifications; no abnormalities were noted.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: ENDO SMARTCAP
• Common Device Name: TUBING SET
• 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: 24203869
• Report Number: 1651395-2026-00003
• Device Sequence Number: 21248254
• Product Code: FAJ
• UDI-Device Identifier: 00677964111075
• UDI-Public: (01)00677964111075(17)281020(10)674144
• 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): 01/28/2026

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)674144
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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