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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM OPTICS CO., LTD. MITO FACTORY FUJINON GASTROSCOPE

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FUJIFILM OPTICS CO., LTD. MITO FACTORY FUJINON GASTROSCOPE Back to Search Results
Model Number EG-450WR5
Device Problems Degraded (1153); Kinked (1339); Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 02/12/2016
Event Type  malfunction  
Manufacturer Narrative
On (b)(4) 2016, a fujifilm sales representative visited the facility and reported the following: after the facility staff reviewed current processes, it was discovered that the dilution ratio of steris prolystica 2x concentrate enzymatic pre-soak and cleaner was inadequate and inconsistent with the ifus for that product. It was determined that the manual cleaning sink had a volume of 8. 5 gallons to the fill line. A measurement of the steris acu-sinq dosing system supplying automated dosing of prolystica 2x enzymatic cleaner was providing only a total of 0. 75 fluid ounces per dosing cycle. According to manufacturer's ifus, the detergent should be diluted 1/8 to 1/2 fluid oz per gallon of warm water. The staff determined that the ratio of detergent to water was inadequate. The customer contacted steris, and made changes to the dosing system parameters to achieve 0. 5 fluid ounces per gallon, for a total of 4. 25 oz concentrated detergent (per 8. 5 gals of water to the fill line in the sink). The facility reported that during this time they had instituted culturing of flexible endoscopes, no contaminated endoscopes were cleared for patient use until after negative culturing results were obtained. Therefore, the scopes which had tested positive were not used clinically (until they again cultured negative). To the best of our knowledge, no reports of infections or complications occurred post endoscopic procedures, and no harm came to any patients associated with these endoscopic procedures. The subject gastroscope was received at fujifilm medical systems endoscopy division on 02/15/2016, inspected and found to have a kinked biopsy channel, a kinked suction channel and slightly damaged, badly scratched and discolored plastic distal end cap. Fujifilm has made repeated requests to visit the facility to investigate the reported events. However, as of 03/10/2016 no approval for a visit has been received and limited answers have been provided to our specific questions. From the lack of detailed information available it is difficult to determine a definitive root cause, however, the use of a 6 fold less concentrated cleaning solution than recommended by its manufacturer combined with kinked instrument/suction channels which could limit or impede successful mechanical cleaning of channel surfaces cannot be ruled out as contributory factors to the inadequate reprocessing of the returned instrument. It should be noted that a total of 4 mdr's (nos. 2431293-2016-00013 through 2431293-2016-00016) are being submitted for 4 endoscopes associated with the reported event at this healthcare facility.
 
Event Description
Staff at (b)(6) is performing cdc recommended culturing of flexible endoscopes. Results indicated pathogens positive for cre during lab testing on four endoscopes.
 
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Brand NameFUJINON
Type of DeviceGASTROSCOPE
Manufacturer (Section D)
FUJIFILM OPTICS CO., LTD. MITO FACTORY
4112 tono
hitachiomiya city ibaraki, 319-2 224
JA 319-2224
Manufacturer (Section G)
FUJIFILM OPTICS CO., LTD. MITO FACTORY
4112 tono
hitachiomiya city ibaraki, 319-2 224
JA 319-2224
Manufacturer Contact
john brzezinski
10 high point drive
wayne, NJ 07470
9736862430
MDR Report Key5494645
MDR Text Key40138672
Report Number2431293-2016-00013
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEG-450WR5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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