MAUDE Adverse Event Report: MEDIVATORS INC. ENDOGATOR KIT

Model Number	4005470
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
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 during a patient procedure that their endogator tubing set broke which resulted in a procedure delay.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.It was found that the tubing was damaged, however an exact cause of the observed damage could not be determined.Steris offered in-service training on the proper use and operation of the endogator tubing; however, the user facility declined.A complaint review determined that this is an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: ENDOGATOR KIT
• Common Device Name: ENDOGATOR KIT
• 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: 22107999
• Report Number: 1651395-2025-00013
• Device Sequence Number: 20588904
• Product Code: OCX
• UDI-Device Identifier: 40677964027978
• UDI-Public: (01)40677964027978(17)280312(10)1000277560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102855
• 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): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4005470
• Device Catalogue Number: 4005470
• Device Lot Number: (10)1000277560
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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