MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM; 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 03/15/2018

Event Type  malfunction  

Event Description

Fujifilm has been informed that the subject endoscope was cultured and tested positive for over 100 cfu involving multiple low/moderate microorganisms such as sphingomonas paucimobilis, dermabacter hominis, staphylococcus pettenkoferi and corynebacterium striatum.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 organisms were present.The endoscope was sent back to fujifilm for instrument inspection/evaluation by fujifilm, and no device failure was confirmed.

• Brand Name: FUJIFILM
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai; kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: tetsuya kawanishi ; 798 miyanodai; kaisei-machi; ashigarakami-gun, kanagawa 258-8-538 ; JA 258-8538
• MDR Report Key: 7428307
• MDR Text Key: 106022634
• Report Number: 3001722928-2018-00049
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152257
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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: 04/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2011
• 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