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

Model Number	100610
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities were noted.As the device is not available for evaluation, a root cause of the reported event cannot be determined.Steris performed in-service training on the proper use and operation of the endogator hybrid irrigation tubing.Steris will continue to monitor for similar events to ensure the product continues to perform as expected.No additional issues have been reported.
Event or Problem Description
The user facility reported that their endogator hybrid irrigation tubing unclamped causing water to leak out onto the floor.An employee slipped and fell on the water and obtained a bruise.No medical treatment was sought or administered.
Event or Problem Description
The user facility reported that their endogator hybrid irrigation tubing unclamped during clean up between cases causing water to leak out onto the floor.An employee slipped and fell on the water and obtained a bruise.No medical treatment was sought or administered, and the employee continued working.
Additional Manufacturer Narrative
An in-depth investigation was conducted and determined that the cause of the tubing not staying clamped was attributed to the tip (point) of the clip.The tip is seated within the "teeth" of the clip to keep the clip engaged/closed.As the tip was not sharp/pointy enough, this allowed the tip to detach from the teeth resulting in the reported issue.

• Brand Name: ENDOGATOR HYBRID 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: 16654628
• Report Number: 1651395-2023-00007
• Device Sequence Number: 6616119
• Product Code: OCX
• UDI-Device Identifier: 00677964052361
• UDI-Public: 00677964052361
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/31/2023

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: 100610
• Device Lot Number: 550858
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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