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

Model Number	100305
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A facility reported that a defendo disposable air/water valve malfunctioned by spurting irrigation fluid during the priming phase of an endoscope procedure.It was reported this fluid spurted into the eye of the physician while handling.The physician reported that the leak was observed while priming the valve and checking all buttons on the endoscope before starting the procedure, therefore no risk to the patient.The water spurted out the top of the disposable valve button.It was reported that the physician was wearing eye protection.It is unknown if the physician sought additional medical attention.Medivators field staff and ra has contacted this customer regarding this complaint.Replacement product was provided.This complaint will continue to monitored within medivators complaint system.
Event or Problem Description
A facility reported that a defendo disposable air/water valve malfunctioned by spurting irrigation fluid during the priming phase of an endoscope procedure.Some of this fluid spurted into the eye of the physician while handling.

• Brand Name: DEFENDO AIR/WATER DISPOSABLE VALVE
• Common Device Name: DISPOSABLE AIR/WATER VALVE FOR GI ENDOSCOPES
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• MDR Report Key: 6073568
• Report Number: 1651395-2016-00003
• Device Sequence Number: 887815
• Product Code: ODC
• UDI-Device Identifier: 00677964060250
• UDI-Public: 00677964060250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 11/02/2016

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?: Yes
• Operator of Device: Physician
• Device Model Number: 100305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 11/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1