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

Model Number	100145CO2EXT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a leak from their endo smartcap tubing.No report of injury.
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without return of the device, a cause cannot be determined.The dhr for the lot subject of this event was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: ENDO SMARTCAP
• Common Device Name: ENDO SMARTCAP TUBING
• 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
• MDR Report Key: 21944720
• Report Number: 1651395-2025-00008
• Device Sequence Number: 12934478
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: (01)00677964059087(17)280212(10)652432
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/01/2025

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: 100145CO2EXT
• Device Lot Number: (10)652432
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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