MAUDE Adverse Event Report: MEDIVATORS INC ENDOGATOR HYBRID TUBING

Model Number	100609
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the lot subject of the reported event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.Steris has requested the endogator hybrid tubing subject of the reported event be returned for evaluation.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure which included use of the endogator hybrid tubing, sterile water leaked from the endoscope.The patient did not require additional medical intervention.No report of injury or procedure delay.
Additional Manufacturer Narrative
The endogator hybrid tubing was not returned for evaluation.Without the returned device, a root cause could not be determined.The endogator hybrid tubing instructions for use states, "always inspect the gi endoscope's o-rings and gaskets (air/water button, gi endoscope connection, etc.) for damage.Damaged components can result in less than optimal performance of the endogator hybrid irrigation tubing.Sterility is not guaranteed if package has been opened or damaged.Do not use if packaging or product is damaged.Endogator hybrid irrigation tubing is for 24 hour use (discard daily).".No additional issues have been reported.

• Brand Name: ENDOGATOR HYBRID TUBING
• Common Device Name: 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: 16725220
• Report Number: 1651395-2023-00010
• Device Sequence Number: 5413792
• Product Code: OCX
• UDI-Device Identifier: 00677964052354
• UDI-Public: 00677964052354
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 04/12/2023
• 2 Devices were Involved in the Event: 1 2

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: 100609
• Device Lot Number: 568733
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 03/16/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/12/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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