PENTAX FI-9RBS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-08-05 for PENTAX FI-9RBS manufactured by Hoya Corporation Pentax Tokyo Office.

Event Text Entries

[51340462] (b)(4). Product code for this device is class 1, therefore this device is exempt from fda 510k. The device involved in the event was not returned to pentax medical since the facility has since validated the cleanliness of the device and the device has tested negative for bacteria. Mfr report #9610877-2016-00153 is being submitted for the first patient involved in the event. Mfr report #9610877-2016-00156 is being submitted for the second patient involved in the event.
Patient Sequence No: 1, Text Type: N, H10


[51340463] On 07/08/2016, pentax medical was made aware of a report in (b)(6) that a pentax sales representative received a call from a facility stating that pentax model fi-9rbs/serial (b)(4) was found to be contaminated with mycobacteria. The pentax sales representative then visited the facility, in which the doctor stated one patient was infected with the same mycobacteria. The pentax sales manager visited the facility on 07/11/2016 to obtain additional event details. The doctor at the facility stated that a patient was found infected with mycobacteria in (b)(6) 2015. In (b)(6) 2016, the patient was again found to be infected with the same mycobacteria. In (b)(6) 2016, another patient was found to be infected with the same mycobacteria. Due to this, the facility cultured a sample from pentax model fi-9rbs/serial (b)(4), which tested positive for the same mycobacteria. All patients from the same hospital ward were then examined and 7 patients were found to be infected with the same mycobacteria. The facility stated pentax model fi-9rbs/serial (b)(4) was not used on all patients who tested positive for mycobacteria, however the source of the infection might possibly be pentax model fi-9rbs/serial (b)(4). Additional information was received from pentax (b)(4) on 08/02/2016 confirming a total of 7 patients tested positive for mycobacteria at this facility. Approx 2 out of these 7 patients who tested positive for mycobacteria underwent procedures with pentax model fi-9rbs/serial (b)(4). On 07/12/2016, two pentax sales representatives and two pentax customer service representatives visited the facility and explained the recommended cleaning and reprocessing methods to one doctor and two nurses. During the visit, it was determined that the facility was not following pentax instructions for use. For example, the facility was not using cleaning liquid. Instead, flowing water was used to clean the endoscope. In addition, brushing was performed but, cleaning liquid was not being flushed into the channel of the endoscope. A clear description on the facility's cleaning method used for cleaning the suction control valve and the rubber inlet seal was not obtained. The high level disinfectant (hld) used at the facility is disopa. The facility did not seem to have sufficient knowledge of the hld controls at the facility. Training on the recommended cleaning and reprocessing methods was completed, and pentax medical is planning on training the facility staff periodically. The device involved in the event was not returned to pentax medical since the facility has since validated the cleanliness of the device and the device has tested negative for bacteria.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610877-2016-00156
MDR Report Key5851882
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-08-05
Date of Report2016-07-08
Date Facility Aware2016-07-08
Report Date2017-12-14
Date Reported to FDA2017-12-14
Date Reported to Mfgr2017-12-14
Date Mfgr Received2016-07-08
Device Manufacturer Date2014-07-28
Date Added to Maude2016-08-05
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 Phone8004315880
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 Received2016-08-05
Model NumberFI-9RBS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age2 YR
Device Eval'ed by MfgrR
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
10 2016-08-05

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