MAUDE Adverse Event Report: MEDIVATORS, INC. ENDOGATOR IRRIGATION TUBING

Model Number	100130
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endogator tubing subject of the reported event is being sent back for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their endogator tubing cracked subsequently causing water to leak out onto the floor.The tubing was replaced subsequently causing a procedure delay.The procedure was completed successfully, and no injuries were reported.
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.Without the returned device, a root cause could not be determined.The device history record (dhr) was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: ENDOGATOR IRRIGATION TUBING
• Common Device Name: IRRIGATION TUBING
• 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: 15987013
• Report Number: 1651395-2022-00034
• Device Sequence Number: 12314187
• Product Code: OCX
• UDI-Device Identifier: 00677964058462
• UDI-Public: 00677964058462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/15/2022

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: 100130
• Device Catalogue Number: 100130
• Device Lot Number: 544545
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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