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

Model Number	100145CO2EXT
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris requested the endo smartcap tubing subject of the reported event be returned for evaluation.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via medwatch mw5175732 that, "after hooking up the endo tubing to the scope, no air or water would come through the scope.Malfunction noted prior to use on patient.No patient harm." no report of injury.
Additional Manufacturer Narrative
Upon the return of the device, steris personnel were unable to locate the endo smartcap tubing subject of the reported event.Without the evaluation of the device, a cause of the reported event could not be determined.The device history record was reviewed and confirmed the subject lot was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: ENDO SMARTCAP
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 23489938
• Report Number: 1651395-2025-00025
• Device Sequence Number: 14648130
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: (01)00677964059087(17)280611(10)663214
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 11/06/2025

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)663214
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 04/13/2026
• 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