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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
Model Number EG16-K10
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Event Description
Pentax medical became aware of a report for an event which occurred in (b)(6) stating, "trouble with broken up angle wire" involving pentax model eg16-k10/serial (b)(4).The event was reported to have occurred in the operating room during pre-use inspection.
 
Manufacturer Narrative
Pentax model eg16-k10 is classified as import for export, therefore 510k is not applicable.The device was serviced at a pentax (b)(4) service center.The broken part of the wire was corroded.The staycoil part had a discolored part and was corroded.Flux that seems to be ad2-1, such as green flux adhered to the corroded part.]from past cases, it is known that the corrosion caused by ad2-1 is similar green.Only the staycoil part was corroded.Pentax medical (b)(4) services and r&d team gathered information regarding the repair and found the following deviation.According to the repair manual, the flux used for soldering is brown mr-101, but the actual repaired product had a different flux that seems to be green ad2-1.
 
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Brand Name
PENTAX
Type of Device
VIDEO GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12712041
MDR Text Key284815705
Report Number9610877-2021-00317
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
PMA/PMN Number
REFER TO H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG16-K10
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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