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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 EB15-J10
Medical Device Problem Codes Poor Quality Image (1408); Material Deformation (2976)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
 
Event or Problem Description
Pentax medical (b)(6) service workshop inspected pentax model eb15-j10/serial (b)(4) and confirmed the following: distal body deformed, leaky.Spot in the image.Ift and segments squeezed.The customer complaint was not stated.Service stated the defects were caused by external force.The device is pending repairs.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.
 
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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 Key12306911
Report Number9610877-2021-00423
Device Sequence Number19735799
Product Code EOQ
UDI-Device Identifier04961333221486
UDI-Public4961333221486
Combination Product (Y/N)N
Initial Reporter CountryBU
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
Type of Report Initial
Report Date (Section B) 08/11/2021
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 07/12/2021
Initial Report FDA Received Date08/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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