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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE Back to Search Results
Model Number EB-1570K
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fungal Infection (2419)
Event Date 08/20/2020
Event Type  Injury  
Event Description
Pentax medical was made aware of an event through a return materials authorization request involving pentax medical video bronchoscope model eb-1570k, serial number (b)(4) to be evaluated because it could possibly have caused patients to be infected.The user facility wants it to be checked out completely to verify.The user facility representative for (b)(6) hospital ((b)(6)), responded to good faith efforts(gfe) via email on (b)(6) 2021 and provided case information for two(2) patient cases.A unique mycobacterium (mycobacterium abscessus) was identified in two sequential bronchoscopy cases - all in patients who did not have any radiographic evidence for mycobacterium disease and were asymptomatic - and in each case, the same bronchoscope was used (the scope in question).Both patients have similar strain.Pentax medical video bronchoscope model eb-1570k, serial number (b)(4) has been used on six(6) total patients up until (b)(6) 2020.The facility confirmed they have seven(7) bronchoscopes onsite.Data on date of bronchoscopies and all cultures: (b)(6) 2020: mycobacterium abscessus, (b)(6) 2020: mycobacterium abscessus.The customer owned endoscope has not been received for evaluation or testing as of (b)(6) 2021.Eb-1570k, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.The investigation is in-process.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
 
Manufacturer Narrative
Correction information: f7: follow up #1, f10: changed medical device problem code to : 2993 adverse event without identified device or use problem.F9: age of device.Evaluation summary: as a result of the investigation, it was found that the bacteria causing the infection were not detected from the endoscope.Therefore, we concluded that there is no causal relationship between the endoscope and the patient's infection.
 
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Brand Name
PENTAX
Type of Device
VIDEO BRONCHOSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12321960
MDR Text Key267259283
Report Number2518897-2021-00405
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberEB-1570K
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2022
Distributor Facility Aware Date07/14/2021
Device Age151 MO
Event Location Hospital
Date Report to Manufacturer11/18/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
Patient SexFemale
Patient Weight62 KG
Patient RaceWhite
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