MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS EVIS EXERA II; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number GIF-N180

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fungal Infection (2419)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

Patient's esophagogastroduodenoscopy (egd) was done with an egd scope of unknown status of disinfection.Random cultures of three gastrointestinal scopes were taken and reported as positive for fungus two days later.This patient's egd scope was one of the three that tested positive, and it was returned to service prior to knowing the culture results.The system 83 plus 9 washer-disinfectors in use have been cultured, and the results are pending.The 5.0 micron sediment pre-filter with reportedly blackened sediment-appearing debris in it was changed out after the scope cultures were obtained.These filters are usually changed every 3 months, and this was the first time we have seen this.It is our belief that this occurred as a result of not adequately flushing the water supply when the heat exchanger was repaired two weeks ago.The tubing leading from the hospital water source to the system 83 plus 9 washer-disinfectors has since been changed.

• Brand Name: EVIS EXERA II
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy; center valley PA 18034
• MDR Report Key: 3753218
• MDR Text Key: 4480169
• Report Number: 3753218
• Device Sequence Number: 1
• Product Code: FDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: GIF-N180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CU 5 MICRON WATER PREFILTER. INSTRUMENT; OTHER; LARGER VARIETY SIZES, DTP-9002 SMALL DIAMETER.; SPECIALIST INC. DISTAL TIP PROTECTORS DTP-2007; METRICIDE OP A PLUS; CUSTOM UNTRASONICS, INC SYSTEM 83 SCOPE PROCESSOR.
• Patient Age: 45 YR
• Patient Weight: 100