MAUDE Adverse Event Report: MEDIVATORS HYBRID IRRIGATION TUBING; ENDOGATOR TUBING

Model Number	100609
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient aspirated during an upper gi endoscopy procedure using an olympus hq190 endoscope and was hospitalized for aspiration pneumonia.Medivators endogator hybrid irrigation tubing was being used during the procedure and the facility reported that the tubing was leaking and caused the patient adverse event.The facility reported their endogator hybrid irrigation tubing was leaking during an upper gastrointestinal procedure and caused the patient to aspirate.The endogator hybrid tubing does not come into contact with the patient.The hybrid tubing connects to the sterile water bottle and connects to the scope to providethe flow of water and co2 through the endoscope.The air/water tubing has a backflow valve.It is not anatomically possible for the tubing to be the cause of the aspiration.Medivators field staff and regulatory has visited this facility to observe their set up and use of the product.Medivators personnel confirmed that the facility is using the tubing in accordance with the instructions for use and did not witness the product leaking or any other product related issues.It was observed that there is inconsistency of set up in one procedure room to the next with regards to irrigation pump brand and water bottle brands being used to know what could potentially cause a leak.It has been requested product returned for internal quality investigation.Medivators field staff remain in close contact with this facility and will continue to monitor this account.This has been documented and is being monitored in medivators complaint system.
Event or Problem Description
It was reported that a patient aspirated during an upper gi endoscopy procedure using an olympus hq190 endoscope and was hospitalized for aspiration pneumonia.Medivators endogator hybrid irrigation tubing was being used during the procedure and the facility reported that the tubing was leaking and caused the patient adverse event.

• Brand Name: HYBRID IRRIGATION TUBING
• Common Device Name: ENDOGATOR TUBING
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 7787005
• Report Number: 2150060-2018-00052
• Device Sequence Number: 19284802
• Product Code: OCX
• UDI-Device Identifier: 00677964052354
• UDI-Public: 00677964052354
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K033695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 100609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other