MAUDE Adverse Event Report: MEDIVATORS DISPOSABLE DEFENDO A/W VALVES; DISPOSABLE AIR/WATER VALVE FOR GI ENDOSCOPES

Model Number	100310
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Airway Obstruction (1699); Muscle Spasm(s) (1966)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported during an egd endoscopy procedure the patient's airway was obstructed.The disposable defendo air/water valve was being used during this procedure and thus contributed to the event.During an egd procedure the patient was under anesthesia and the physician reported the defendo air/water valve was sticking/leaking causing water to drip down the patient's throat.This physician reported muscle spasms of the vocal cords which blocked their airway and lead to the patient being intubated.Medivators consulted with four resident experts in gi and they all stated that it is unlikely during a procedure for the physician to leave the distal tip at the juncture of the larynx/trachea and esophagus for an extended period of time that would allow water to get into the patients' vocal cords.The purpose of the defendo air/water valve is for the physician to clear the lens to have better visibility during the procedure which limited amounts of water is used.The physician has complete control of the fluid flow through the endoscope.Regulatory has attempted to contact the facility.Any details of pre-exiting conditions about the patient were not disclosed.The current patient condition is unknown.This complaint will continue to be monitored in the medivators complaint system.
Event or Problem Description
The facility reported during an egd endoscopy procedure the patient's airway was obstructed.The disposable defendo air/water valve was being used during this procedure and thus contributed to the event.
Additional Manufacturer Narrative
The facility reported that during an egd endoscopy procedure, the patient experienced vocal cord muscle spasms.The disposable defendo air/water valve was used during the procedure and was reported to have contributed to the event.The patient was under anesthesia during the procedure and the physician reported the defendo air/water valve was sticking/leaking causing water to drip down the patient's throat.This physician reported the patient experienced vocal cord muscle spasms causing a restricted airway and led to the patient being intubated.Medivators consulted with four resident experts in gi and they all stated that it is unlikely for the physician to leave the distal tip at the juncture of the larynx/trachea and esophagus for an extended period that would allow water to get into the patient's vocal cords.The purpose of the defendo air/water valve is for the physician to clear the endoscope lens to have better visibility during the procedure which a limited amount of water is used.The physician has complete control of the fluid flow through the endoscope.Medivators regulatory has attempted to contact the facility.Any details of pre-existing conditions about the patient were not disclosed.The current condition of the patient is unknown.This complaint will continue to be monitored in the medivators complaint system.
Event or Problem Description
The facility reported that during an egd endoscopy procedure, the patient experienced vocal cord muscle spasms.The disposable defendo air/water valve was used during the procedure and was reported to have contributed to the event.

• Brand Name: DISPOSABLE DEFENDO A/W VALVES
• Common Device Name: DISPOSABLE AIR/WATER VALVE FOR GI ENDOSCOPES
• Manufacturer (Section D): MEDIVATORS; 3150 pollock drive; conroe TX 77303
• MDR Report Key: 8343345
• Report Number: 1651395-2019-00001
• Device Sequence Number: 1959082
• Product Code: ODC
• UDI-Device Identifier: 00677964052453
• UDI-Public: 00677964052453
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K102409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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 Expiration Date: 10/20/2021
• Device Model Number: 100310
• Device Lot Number: 935350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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: Other