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Model Number ED-3490TK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Mdr 9610877-2017-00412 is being submitted for #4 patient/case#2.Mdr 9610877-2017-00417 is being submitted for #1 patient.Mdr 9610877-2017-00418 is being submitted for #2 patient.Mdr 9610877-2017-00419 is being submitted for #3 patient.Mdr 9610877-2017-00420 is being submitted for #5 patient.Pentax medical filed mdr 2518897-2015-00017 on 06/23/2015 for an event regarding this scope (serial (b)(4)).The report provided that pentax medical received a customer report on 05/29/2015 stating the facility tests all duodenoscopes for carbohydrates, protein and blood via the health mark industries channel check process and video duodenoscope model ed-3490tk/serial (b)(4) tested positive twice for blood and tested negative after the third wash.
Event Description
A pentax medical customer service representative became aware of a report from a facility contact who left a voice message on (b)(4)2017 in regards to a question on an infection control issue.No further information was received at the time of the report.Pentax medical contacted the facility on 07/14/2017 to obtain additional information regarding this report.Pentax medical received additional information on 07/14/2017 and 07/19/2017 stating pentax model ed-3490tk/(b)(4) was used for a procedure on a patient who presented at the facility with a pre-existing condition described as a mcr-1 bug.Another patient had a procedure performed with the same duodenoscope 9 days later than the first patient and was found to have a similar mcr-1 condition.The additional information also stated the duodenoscope has been under quarantine for approximately the last 30 days.Pentax medical was notified in early june 2017 and during a facility visit on 06/21/2017 in connection with a routine scope inspection that scope (b)(4) had been sequestered due to usage on a compromised patient.The facility stated that scope (b)(4) had tested negative for bacteria.No additional information was provided by the facility at that time.Following the notification by the facility on 07/13/2017, pentax medical visited the facility on 07/26/2017 and received a medsun report (dated 07/23/2017) which states additional details of the event and the actions taken by the facility, federal agencies, and pentax medical.The medsun report states that the reported event is "in regards to the probable transmission of the mcr-1 bacteria via a pentax video duodenoscope (from case #1 to case #2)".The medsun report further provides: "the mcr-1 exposure investigation timeline includes the following: on (b)(6)2017: the first patient (case #1) had an ercp performed.During the procedure, a bile sample was obtained and sent to the hospital's microbiology lab.On (b)(6)2017: the bile sample testing results returned for case #1; this grew ctx-r klebsiella pneumonia.The patient was placed on isolation precautions.The infectious disease physician requested colistin susceptibility testing as part of planning for future treatment of this resistant organism.On (b)(6)2017: the microbiology lab reported the colistin mic = 4 microgram/ml (this was suspicious for mcr-1) (performed by broth dilution).An isolate was sent to the (b)(4) on 05/01/2017.(b)(4) results returned confirming the mcr-1 in case #1.An investigation began to identify if the patient had had any invasive procedures; it was quickly identified that the ercp was the only invasive procedure.The duodenoscope was identified and sequestered on 05/02/2017.Timeline related to exposed patients includes: on (b)(6)2017, the #1 patient had been exposed via the duodenoscope.On (b)(6)2017, the #2 patient had been exposed via the duodenoscope.On (b)(6)2017, the #3 patient had been exposed via the duodenoscope.Each of the above three patients (#1 patient, #2 patient and #3 patient) tested negative for mcr-1.On (b)(6)2017, an exposed #4 patient via duodenoscope later tested positive on (b)(6)2017 for the mcr-1 bacteria.This patient (#4 patient) was identified as case #2.On (b)(6)2017, a #5 patient had been exposed via the duodenoscope.The #5 patient tested negative for the bacteria.On (b)(6)2017, testing done on a wound/drain culture from patient exposed #4/case #2 grew ctx-r klebsiella pneumonia.On (b)(6)/2017, the microbiology lab reported colistin mic = 4 microgram/ml (performed by broth dilution).The isolate was sent to the (b)(4).On (b)(6)2017, the (b)(4) confirmed mcr-1 in case #2.Additional testing from the (b)(4) was requested.On (b)(6)2017, the duodenoscope culture returned negative.Whole genome sequencing (wgs) analysis was ongoing at the (b)(4) including sequential clinical and surveillance isolates from case 1 and 2.Additional information was being received from the (b)(4) regarding the genome sequencing during the month of (b)(6) 2017.The information regarding the strains from case 1 and case 2 received from the (b)(4) was reviewed by hospital leaders from infectious disease, infection control, clinical endoscopy, and quality and safety on (b)(6)2017.The similarity of strains was sufficiently large that the group concluded that there was probable transmission.Definitive evidence is pending the results of additional wgs analysis from the cdc which should return after (b)(6)2017.On 07/14/2017, after communication with the (b)(4), fda and pentax, it was decided that the suspect scope would be sent to the (b)(4) for examination." pentax medical granted permission for the facility to send the duodenoscope to the (b)(4).The duodenoscope, along with 3 new, unopened, and unused, pentax brushes (2 pentax model cs-c9s and 1 pentax model cs-6021t) were forwarded to the (b)(4) on 07/26/2017.A copy of the medsun mandatory and voluntary report form was forward by fda and received by pentax medical on 08/02/2017.The cdc communicated to a pentax representative that their preliminary testing results indicate that the isolates from the patients and the device appear related and a final report would be available in 2-3 weeks of 08/03/2017.The device history record for pentax model ed-3490tk/(b)(4) confirmed the duodenoscope was manufactured under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.
Manufacturer Narrative
Hoya corporation pentax (b)(4), specification developer, registration no.9610877.Pentax of america, inc., importer, registration no.2518897 pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax (b)(4) (exemption number e2015036).Mdr 9610877-2017-00412 is being submitted for #4 patient/case#2; mdr 9610877-2017-00417 is being submitted for #1 patient; mdr 9610877-2017-00418 is being submitted for #2 patient; mdr 9610877-2017-00419 is being submitted for #3 patient; mdr 9610877-2017-00420 is being submitted for #5 patient.
Event Description
The customer complaint investigation final report for pentax model ed-3490tk/serial (b)(4) was received from the manufacturer which included results on the appearance check before disassembly, analysis of attached substances on the duodenoscope, result of studies in accordance with the cleaning efficacy/hld efficacy study protocol, and inspection after disassembling distal end along with analysis of substance detected after disassembling.Pentax medical provided this information to the facility.
Manufacturer Narrative
(b)(4).Pentax (b)(4) office (exemption number e2015036).Mdr 9610877-2017-00412 is being submitted for #4 patient/case#2.Mdr 9610877-2017-00417 is being submitted for #1 patient.Mdr 9610877-2017-00418 is being submitted for #2 patient.Mdr 9610877-2017-00419 is being submitted for #3 patient.Mdr 9610877-2017-00420 is being submitted for #5 patient.
Event Description
The device was received by pentax medical on 03-oct-2017.Reprocessing of the device was not performed.Pictures were taken of the distal tip by pentax medical service.The device was shipped to the manufacturer for evaluation/investigation.The device was received by the manufacturer on 11-oct-2017.Sterilization of the device was completed on 18-oct-2017.Inspection of the distal tip was performed on 31-oct-2017, which confirmed all seal surfaces observed were continuous and smooth with no outward signs of discontinuity, gaps, and bubbles.The device is currently undergoing further evaluation/investigation.Additional information regarding reprocessing details and techniques followed at the facility including chemicals, brushes, aer manufacturer/model/serial, manual and sterilization processes for this device was requested.The following information was received: duodenoscope is precleaned with ruhof detergent and sterile water with emphasis on elevator mechanism post patient procedure by medical team assigned to room- per the updated 2016 pentax ifu for duodenoscopes.Duodenoscope is bagged and transported to reprocessing room immediately after procedure.Duodenoscope transport tray is tagged by medical team, to identify it as a priority item for immediate processing.Scope is dry leak tested- upon passing this test, it is then wet leak tested.If it does not pass the dry or wet leak test, it is tagged for service review and forwarded to the reprocessing supervisor.Scope exterior is cleaned with ruhof manufacture's recommended detergent specifications- ruhof detergent #345ap endozime aw plus.Pentax manufactured brushes are used with duodenoscope reprocessing- brush model's cs602it and cs-c9s.Brushing of all pertinent channels is completed as per the updated pentax 2016 ifu for duodenoscope reprocessing - including required elevator mechanism brushings and flushing's.Flushing and rinsing of the duodenoscope channels is completed by the custom ultrasonic automated sink process.Health mark channel testing is performed for any remaining carbohydrates; blood, or protein.Duodenoscope (b)(4) showed negative results.Duodenoscope is placed and contained in a sealed transport cart, then forwarded to gray 3 o.R.Endoscopy for aer processing.Medivator hook up # 2-8-43-1 han was connected to all ports in the (b)(4) duodenoscope.Duodenoscope is placed into the medivators advantage system plus washers for two 37 minute cycles of washing and high level rapicide disinfection (serial number of the washer that (b)(4) was processed in during this time is unknown).Duodenoscope is removed from medivator washer, and medical air dried for three minutes.Duodenoscope is tagged with a five day expiration label.Duodenoscope is placed into a sealed contained clean transport cart.Duodenoscope is hung vertically in temperature regulated clean scope storage closet designed especially for this equipment.The facility confirmed that medivator advantage system plus washers and high level rapicide disinfection are compatible with the device.The medivator washers are properly maintained and the facility has been following the method of high level disinfection recommended by medivators.The facility also stated the device was reprocessed after the last patient prior to sequestration/quarantine, at which point it was sent to the centers for disease control & prevention.Pentax medical received a report from the centers for disease control & prevention on 25-oct-2017.The report stated: one duodenoscope (manufacturer, pentax medical; sn (b)(4)) related to potential transmission of mcr-producing klebsiella pneumoniae between patients was received by the environmental and applied microbiology lab for testing by culture-dependent methods.Test methods: sampling of the duodenoscope was modified based on methods described at https://www.Cdc.Gov/hai/settings/lab/lab-duodenoscope-sampling.Html.The sampling of the duodenoscope produced the following specimens: 50 ml rinse of 0.85% sterile saline of the instrument channel; brush used to sample the distal end including the forceps elevator region; 4 ml sterile saline rinse of the channel and the forceps elevator region while raising and lowering the elevator.Culturing of the duodenoscope specimens was performed as described at https://www.Cdc.Gov/hai/settings/lab/lab-duodenoscope-culture-method.Html using the culture method a - presence/ absence by enrichment method.The saline from the elevator raising and lowering sampling was also cultured using culture method a.Species id: suspect isolates were identified by an automated biochemical identification system (vitek 2, biomérieux, (b)(4)), or by maldi-tof (maldi biotyper, bruker daltonics, (b)(4)) using the bruker and microbenet ( https://microbenet.Cdc.Gov/ ) databases; species-level identification is confident for scores >=2.0.Mechanism testing: dna was extracted directly from broth using a maxwell 16 instrument (promega, (b)(4)).Detection of the mcr gene was performed using a pcr assay.Whole genome sequencing and analysis: dna was extracted from the isolate using the automated nucleic acid purification maxwell® 16 mdx research (promega, (b)(4) instrument according to the manufacturer's recommendations.High quality input gdna, indicated by an absorbance ratio of 1.8-2.0, were fragmented by covaris® ((b)(4)) ultrasonic fragmentation.The gdna sample library was then prepared using the nugen® ovation ultralow dr multiplex system 1-96 kit ((b)(4)).Lastly, the library was multiplexed and sequenced with the illumina® miseq instrument ((b)(4)) yielding 250 bp paired-end reads.The illumina reads were screened for phix contamination using the bbduk program (https://sourceforge.Net/projects/bbmap/), and low quality/adapter trimming was carried out by trimmomatic.We constructed genome assemblies from high quality sequencing reads using the de novo assembly algorithm, spades.Phylogenetic analysis was performed by identifying high quality single nucleotide variants (snvs) using the snvphyl pipeline as well as using bionumerics whole genome multilocus sequence typing (wgmlst) for k.Pneumoniae.For snvphyl, an unrelated st-15 klebsiella pneumoniae genome downloaded from ncbi ((b)(4)) served as a reference and outlier.All isolates were blast against the resfinder database (https://cge.Cbs.Dtu.Dk/services/resfinder/).Results summary: two gram-negative enteric bacteria, escherichia coli and klebsiella pneumoniae, were recovered from the channel flush/brush (2017-32-36) and the tip flush/brush (2017-32-37) specimens.Pcr mechanism testing indicated that all e.Coli and k.Pneumoniae isolates were negative for the mcr gene.Scant low-concern organisms were recovered from the rinse simultaneous to elevator raising and lowering.Wgs indicates that all k.Pneumoniae isolates, both clinical and from the duodenoscope, belong to sequence type st-15.Phylogenic analyses with snvphyl (figure 1, table 3) and bionumerics wgmlst (figure 2) both demonstrate that the clinical isolates form a cluster that is distinct from the duodenoscope isolates.Clinical and isolate antibiotic resistance gene profiles were unique (table 1).All the patient samples had mcr-1 (with an atypical ata start codon), catb4, oxa-1, and shv-28 alleles,that are not seen in any of the duodenoscope samples.Conversely, all the duodenoscope samples had aac6-iic, flor, and oxa-10 alleles, which are not detected in any of the clinical isolates.
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Brand Name
Type of Device
Manufacturer (Section D)
tsutsujigaoka 1-1-110
tokyo, 196-0 012
JA  196-0012
Manufacturer (Section G)
tsutsujigaoka 1-1-110
tokyo, 196-0 012
JA   196-0012
Manufacturer Contact
matthew vernak
3 paragon drive
montvale, NJ 07645
MDR Report Key6789702
MDR Text Key83319423
Report Number9610877-2017-00417
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/18/2018,07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberED-3490TK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2018
Distributor Facility Aware Date07/13/2017
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer01/18/2018
Date Manufacturer Received12/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1