MAUDE Adverse Event Report:; ENDOSCOPE ACCESSORIES

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

A fujifilm field service engineer will arrange a site visit to perform an in service on endoscope and accessory handling, cleaning and disinfection recommendations.

Event Description

On (b)(6) 2017, a fujifilm field service engineer observed a customer not following cleaning and disinfection recommendations for endoscope accessories.The customer is not routinely disinfecting water bottles, is reusing jet wash tubing (which should be replaced daily), not replacing jet wash check valves after each case and not replacing suction tubing after each case.

• Type of Device: ENDOSCOPE ACCESSORIES
• Manufacturer Contact: john brzezinski ; 10 high point drive; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 6710282
• MDR Text Key: 80177995
• Report Number: 2431293-2017-00071
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1