Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE Back to Search Results
Model Number EB15-J10
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/15/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to a physical damage applied on the lg cable connector housing.This report is being filed as part of the pentax backlog management plan.
 
Event or Problem Description
Leak of the pve connector at first use.Without any use and during the first reprocessing before sampling, users noticed a significant leak on the pve connector.It has not been detected with sha-p6.The intensity is an air bubble each 3 seconds and it is located at the junction between the lg cable connector ass'y and the housing.The time of event is unknown.There was no report of patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PENTAX
Common Device Name
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 Key12194404
Report Number9610877-2021-10400
Device Sequence Number1480531
Product Code EOQ
UDI-Device Identifier04961333225453
UDI-Public04961333225453
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K200678
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberEB15-J10
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/19/2021
Initial Report FDA Received Date07/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-