MAUDE Adverse Event Report: FUJIFILM OPTICAL CORPORATION, MITO FACTORY FUJINON; DUODENOSCOPE

Model Number ED-530XT

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2014

Event Type  Other  

Event Description

On (b)(6) 2014, fujifilm medical systems u.S.A., inc.(fmsu) was contacted by (b)(6) hospital and advised on fujinon (note: fmsu's endoscopes bear the brand name of "fujinon") duodenoscopes and patients testing positive for cre (carbapenem-resistant enterobacteriaceae).

Manufacturer Narrative

Fujifilm medical systems u.Sa., inc.(fmsu) immediately initiated an investigation, including a visit to (b)(6), to identify the root cause for the incident.Fmsu personnel were informed that, in response to cre incidents at its sister hospital, (b)(6) had conducted a review of prior medical records for its patient who were positive for cre.At the time of this report, fmsu has been advised that two of three endoscopes ((b)(4)) have allegedly been cultured positive for cre.Three patient who had undergone ercp procedures tested positive for cre and two of three of these patients expressed symptoms consistent with positive cre.The customer is unsure whether the patient transferred cre to the endoscope or vice versa.Non-fujifilm equipment, including a channel cleaning device instead of cleaning brush, is used to manually clean the endoscopes and an aer is used for automated high-level disinfection.A review of fmsu service records for (b)(6) indicated no abnormalities other than general wear and tear repairs attributable to normal usage and handling of the device.Fmsu has requested but has not received any information on any treatment or hospitalizations for these patients, at the time of this initial report.In addition, fmsu has requested that the duodenoscopes that tested positive for cre be returned for a detailed examination.To date, the customer has not returned any duodenoscopes to fmsu.The investigation is still ongoing.Fmsu will submit a supplemental mdr once the investigation is completed.

• Brand Name: FUJINON
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): FUJIFILM OPTICAL CORPORATION, MITO FACTORY; 4112 tono; hitachiomiya city, ibaraki 319- 2224; JA 319-2224
• Manufacturer (Section G): FUJIFILM OPTICAL CORPORATION; 4112 tono; hitachiomitya city, ibaraki 319- 2224; JA 319-2224
• Manufacturer Contact: mary moore ; 10 high point dr.; wayne, NJ 07470 ; 9736862498
• MDR Report Key: 3958702
• MDR Text Key: 4560315
• Report Number: 2431293-2014-00001
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ED-530XT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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
• Patient Outcome(s): Other