MAUDE Adverse Event Report: MEDIVATORS INC ENDOGATOR HYBRID TUBING SET

Model Number	100608
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endogator hybrid tubing subject of the reported event was returned for evaluation.During inspection of the tubing, it was observed that the backflow valve component was not affixed to the tubing subsequently causing the reported event to occur.The user facility also returned samples from the subject lot.All samples returned had no issues noted.A complaint review determines this to be an isolated event.Steris offered in-service training to user facility personnel on the proper use and operation of the endogator tubing and to specifically pretest the tubing prior to use.The instructions for use states, "the backflow valve attached to the endogator hybrid irrigation tubing must be in place.If the backflow valve is missing, then discard the entire endogator hybrid irrigation tubing, accessories and water bottle." no additional issues have been reported.
Event or Problem Description
The user facility reported that the tubing connector to their endogator hybrid tubing disconnected subsequently causing water to leak.No report of injury.
Additional Manufacturer Narrative
Steris performed in-service training to user facility personnel on the proper use and operation of the endogator tubing, specifically the importance of pretesting the tubing prior to use.No additional issues have been reported.

• Brand Name: ENDOGATOR HYBRID TUBING SET
• Common Device Name: TUBING SET
• Manufacturer (Section D): MEDIVATORS INC; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 18867928
• Report Number: 1651395-2024-00012
• Device Sequence Number: 7879141
• Product Code: OCX
• UDI-Device Identifier: 00677964060861
• UDI-Public: 00677964060861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/08/2024

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: 100608
• Device Catalogue Number: 100608
• Device Lot Number: 606623
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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