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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr for the lot subject of the event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.The endogator irrigation tubing subject of the reported events was returned to medivators for evaluation and confirmed that the area of the tubing that is placed into the pump head was damaged.Additionally, the pump heads were also returned for evaluation and confirmed it to be operating according to specification.After further testing, it was determined that the damage most likely occurred as a result of incorrect placement of the pump tube into the pump head by user facility personnel.The endogator irrigation tubing ifu states,"open the pump head.Place the printed section of the irrigation tubing, where the text "place in pump head" is printed, in the pump head and close.(note: ensure that the text "place in pump head" is centered, aligned and carefully pulled taut before closing the pump head.) take care to prevent the connector from touching the ground." no additional issues have been reported.
Event or Problem Description
The user facility reported that their endogator irrigation tubing was cracked and leaking.No report of injury or procedure delay.

• 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: 18326252
• Report Number: 1651395-2023-00049
• Device Sequence Number: 6951788
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: 489460
• 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: 03/26/2021
• Initial Report FDA Received Date: 12/14/2023
• 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