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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; NON-RIGID LARYNGOSCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; NON-RIGID LARYNGOSCOPE Back to Search Results
Model Number FI-10RBS
Device Problem Device Reprocessing Problem (1091)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 06/07/2017
Event Type  Death  
Manufacturer Narrative
Three patients are mentioned in this mdr.The first patient indicated the presence of klebsiella pneumoniae at the time of the fibroscopy.The second patient underwent a fibroscopy with the same scope, after the first patient, and became infected with klebsiella pneumoniae.The third patient had a fibroscopy on (b)(6) 2017 with no reported adverse events.Mdr 9610877-2017-00406 is being submitted for the second patient involved in the cross contamination event.Mdr 9610877-2017-00407 is being submitted for the third patient who had a fibroscopy on (b)(6) 2017.(b)(4).Exempt = product code is class 1, exempt from fda 510(k).
 
Event Description
On 07/12/17, pentax medical was made aware of a report from the (b)(6) regarding an event in (b)(6) of cross contamination of klebsiella pneumoniae via a fiberscope (fi-10rbs serial no.(b)(4)) between 2 patients in cardiothoracic intensive care on (b)(6) 2017.(b)(6) reported that the first patient indicated the presence of the bacteria at the time of the procedure and the second patient tested positive following the procedure.(b)(6) reported that the 2 patients died from their underlying pathologies.(b)(6) reported that a third patient who had a fibroscopy on (b)(6) 2017 (before the endoscope was quarantined) was informed of the possible exposure and has no clinical signs of infection.(b)(6) further reported that the endoscope was still contaminated despite disinfection.The fiberscope was received by pentax (b)(4) from the facility on (b)(6) 2017 without any information about the contamination.The inspection found a perforated bending rubber.The fiberscope was repaired and reprocessed.Microbiological sampling was performed on the fiberscope on (b)(6) 2017.The sampling laboratory reported the following results: operating channel 1 cfu of bacillus sp., suction channel <1 cfu.A request for the device to be shipped from pentax (b)(4) to pentax europe (b)(4) was made on 07/13/2017.Pentax europe (b)(4) received the fiberscope ((b)(4)) on 07/17/2017.Inspection performed by pentax europe (b)(4) found the fiberscope to be leaky at the control body at the valve seat and appeared to have been previously repaired.In addition, the device looked worn, many scratches were noted and the insertion flexible tube was buckled and squeezed.Microbiological sampling was performed on the fiberscope on (b)(6) 2017.Results showed no critical pathogens, therefore the device met the hygienic microbiological requirements.A device history review was performed by the manufacturer which showed no discrepancies.The device is currently at pentax europe (b)(4).Pentax europe (b)(4) and pentax (b)(4) are currently investigating the event.
 
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Brand Name
PENTAX
Type of Device
NON-RIGID LARYNGOSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi
tokyo, 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi
tokyo, 196-0 012
JA   196-0012
Manufacturer Contact
matthew vernak
3 paragon drive
montvale, NJ 07645
2015712300
MDR Report Key6789915
MDR Text Key82602004
Report Number9610877-2017-00406
Device Sequence Number1
Product Code CAL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
REFER TO H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 08/11/2017,07/12/2017
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFI-10RBS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2017
Distributor Facility Aware Date07/12/2017
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer08/11/2017
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
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