MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. OLYMPUS TJFQ180V; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 12/01/2012

Event Type  malfunction  

Event Description

This report is in response to an fda audit conducted late last year.The fda representatives suggested that this be entered into medsun, not because there was an equipment issue but because equipment was part of a larger infection control investigation.During routine infection control surveillance approximately three and one half years ago, it was noted by infection control that there was an increase in patients with positive blood cultures for esbl + klebsiella following ercp procedures.Further investigation identified prior cases one to two months earlier (prior to the approximate date of three and one half years ago); through the beginning of the following year (post the approximate date of three and one half years ago) there were 11 cases of bacteremia.Molecular typing was conducted that determined that several patients had unrelated infection.However, 6 patients were noted to have the same strain or related strain of the organism.Extensive investigation was conducted to determine the root cause which included culturing of the scopes used on these patients, culturing the environment including the cleaning of sinks and the reprocessors, monitoring the disinfection process and reviewing the staffing patterns.All the cultures of the scopes, reprocessors, environment and sinks were negative.Despite the negative cultures, disinfection with hydrogen peroxide was performed in both the procedure room and in the reprocessing area.

• Brand Name: OLYMPUS TJFQ180V
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 3500 corporate parkway; center valley, PA 18034
• MDR Report Key: 5684549
• MDR Text Key: 46091049
• Report Number: 5684549
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1