MAUDE Adverse Event Report: MEDIVATORS INC ENDOGATOR HYBRID TUBING

Model Number	100610
Medical Device Problem Codes	Leak/Splash (1354); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, which included use of the endogator hybrid tubing and endo stratus co2 insufflator, water leaked from the endoscope while near the airway leading to an oxygen drop.Additional oxygen was given to the patient and the procedure was completed successfully.No report of procedure delay.
Additional Manufacturer Narrative
The customer returned their endo stratus co2 insufflator to medivators for evaluation and no issues were noted with the function or operation of the unit.The endogator hybrid tubing subject of the reported event was returned for evaluation and found to be operating according to specification.The lot number of the returned tubing is unknown.Directions in the instructions for use include "connect the air/water connector of the endogator hybrid irrigation tubing to the air/water port of the gi endoscope with a firm pushing motion.Prime the tubing and the auxiliary water channel prior to use by activating the foot pedal; flush water through the entire gi endoscope.Turn on the air processor or co2.Prime the channel and test for air and water prior to insertion of gi endoscope into patient.If the water pressure is low, then ensure that the water bottle is tightly closed.".Medivators has contacted the customer for additional information regarding the operating conditions at the time of the event; however, to date we have not received a response.A follow-up mdr will be submitted should additional information become available.
Additional Manufacturer Narrative
At the time of the reported event, the endo stratus co2 insufflator and the endogator hybrid tubing was being used for an upper and lower endoscopy procedure.A steris product specialist completed in-service training on the proper use and operation of the endo stratus co2 insufflator and endogator hybrid tubing.No additional issues have been reported.
Additional Manufacturer Narrative
Further investigation into the root cause of the reported event was conducted.Based on the description of the reported event and the evaluation results of the returned device, it is likely that the pump tube was incorrectly placed within the pump head by user facility personnel.Should the pump tube be incorrectly placed, this can allow water to pass beyond the pump head and dispense water at the distal end of the scope resulting in the reported event.Users are expected to follow the instructions outlined for placing the pump tube, as stated within the endogator hybrid irrigation tubing instructions for use (ifu).For endogator hybrid irrigation tubing models with an imprint on the tube segment placed within the pump head, the ifu states, "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." for endogator hybrid irrigation tubing models with connectors defining the tub segment placed within the pump head, the ifu states, "open the pump head, insert the pump tube of the irrigation tubing and close the pump head.(note: ensure that the pump tubing between the tubing connectors is centered, aligned, and carefully pulled taut before closing the pump head." directions in the ifu also include "connect the air/water connector of the endogator hybrid irrigation tubing to the air/water port of the gi endoscope with a firm pushing motion.Prime the tubing and the auxiliary water channel prior to use by activating the foot pedal; flush water through the entire gi endoscope.Turn on the air processor or co2.Prime the channel and test for air and water prior to insertion of gi endoscope into patient.If the water pressure is low, then ensure that the water bottle is tightly closed." 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: 16781432
• Report Number: 1651395-2023-00011
• Device Sequence Number: 17819818
• Product Code: OCX
• UDI-Device Identifier: 00677964052361
• UDI-Public: 00677964052361
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/20/2023

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
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023; 03/22/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/01/2023; 11/02/2023
• 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