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U.S. Department of Health and Human Services

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

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FUJIFILM OPTICAL CORPORATION, MITO FACTORY FUJINON DUODENOSCOPE Back to Search Results
Model Number ED-530XT
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.

 
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Brand NameFUJINON
Type of DeviceDUODENOSCOPE
Manufacturer (Section D)
FUJIFILM OPTICAL CORPORATION, MITO FACTORY
4112 tono
hitachiomiya city, ibaraki 319- 2224
JAPAN 319-2224
Manufacturer (Section G)
FUJIFILM OPTICAL CORPORATION
4112 tono
hitachiomitya city, ibaraki 319- 2224
JAPAN 319-2224
Manufacturer Contact
mary moore
10 high point dr.
wayne , NJ 07470
9736862498
MDR Report Key3958702
Report Number2431293-2014-00001
Device Sequence Number1
Product CodeFDT
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 Received06/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberED-530XT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/20/2014 Patient Sequence Number: 1
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