MAUDE Adverse Event Report: MEDIVATORS INC DEFENDO; ENDOSCOPE CHANNEL ACCESSORY

Model Number 100303

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Rn noted spraying on side of face while forceps through defendo; no mucosal contact.Procedure ended unremarkably and scope tested without forceps in biopsy port: a fine stream was noted extending straight out from the orifice of the defendo approximately 5 feet.

• Brand Name: DEFENDO
• Type of Device: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): MEDIVATORS INC; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 3983119
• MDR Text Key: 4632109
• Report Number: 3983119
• Device Sequence Number: 1
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 100303
• Device Lot Number: 725593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1