PENTAX FI-10RBS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-08-11 for PENTAX FI-10RBS manufactured by Hoya Corporation Pentax Tokyo Office.

Event Text Entries

[82602004] 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).
Patient Sequence No: 1, Text Type: N, H10


[82602005] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610877-2017-00406
MDR Report Key6789915
Report SourceFOREIGN
Date Received2017-08-11
Date of Report2017-07-12
Date of Event2017-06-07
Date Facility Aware2017-07-12
Report Date2017-08-11
Date Reported to FDA2017-08-11
Date Reported to Mfgr2017-08-11
Date Mfgr Received2017-07-12
Device Manufacturer Date2014-08-05
Date Added to Maude2017-08-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MATTHEW VERNAK
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE NJ 07645
Manufacturer CountryUS
Manufacturer Postal07645
Manufacturer Phone2015712300
Manufacturer G1HOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer StreetTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI
Manufacturer CityTOKYO, 196-0012
Manufacturer CountryJA
Manufacturer Postal Code196-0012
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENTAX
Generic NameNON-RIGID LARYNGOSCOPE
Product CodeCAL
Date Received2017-08-11
Returned To Mfg2017-07-03
Model NumberFI-10RBS
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age3 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer AddressTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI TOKYO, 196-0012 JA 196-0012


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2017-08-11

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