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

Model Number FI-9RBS

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

(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.This report is being submitted for the first patient involved in the event.The 9610877-2016-00156 is being submitted for the second patient involved in the event.

Event Description

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 (b)(6) 2016 confirming a total of 7 patients tested positive for mycobacteria at this facility.Two (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.

Manufacturer Narrative

(b)(4).(exemption number e2015036).

Event Description

On 25/oct/2016, a device history review was performed which confirmed the non-rigid laryngoscope, was manufactured under normal conditions, passed all required inspections, and was released accordingly.In addition, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.Since no further information has been received for this event, pentax medical considers this medwatch report closed.

• 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 ; 8004315880
• MDR Report Key: 5851872
• MDR Text Key: 51347635
• Report Number: 9610877-2016-00153
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017,07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FI-9RBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2017
• Distributor Facility Aware Date: 07/08/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2017
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: 07/08/2016
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1