MAUDE Adverse Event Report: FUJIFILM TECHNO PRODUCTS, MITO FACTORY FUJINON; DUODENOSCOPE

Model Number ED-530XT

Device Problems Microbial Contamination of Device (2303); Contamination /Decontamination Problem (2895); Device Contamination With Biological Material (2908)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2017

Event Type  malfunction  

Event Description

Fujifilm has been informed that the subject endoscope was cultured and tested positive for klebsiella pneumoniae.As the subject unit was being sampled and cultured as part of a postmarket surveillance activity, no patients were involved or exposed to the endoscope.Per study protocol, the endoscope was immediately quarantined after initial sampling, until culturing data were available.Following the positive culture, the endoscope was not clinically reused.The additional sampling and culturing were performed after the second disinfection, and confirmed that no high concern organism were present.The endoscope was sent back to fujifilm for instrument inspection/evaluation by fujifilm, and no device failure was confirmed.

• Brand Name: FUJINON
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): FUJIFILM TECHNO PRODUCTS, MITO FACTORY; 4112 tono; hitachiomiya city, 319-2 224; JA 319-2224
• Manufacturer (Section G): FUJIFILM TECHNO PRODUCTS, MITO FACTORY; 4112 tono; hitachiomiya city, 319-2 224; JA 319-2224
• Manufacturer Contact: john brzezinski ; 10 high point drive; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 6866947
• MDR Text Key: 87303741
• Report Number: 2431293-2017-00077
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ED-530XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1