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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL RADIAL ULTRASOUND SCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL RADIAL ULTRASOUND SCOPE Back to Search Results
Model Number EG36-J10UR
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
Pentax medical became aware of a report for an event which occurred in the (b)(6) stating, "puk: leaking from ift root brace." involving pentax ultrasound videoscope model eg36-j10ur/serial (b)(4).There was no report of death, serious injury or other significant/important medical event.No further information was provided at the time of the report.The device was returned to pentax medical (b)(4) service workshop where the following was confirmed: ift loosened, leaky.The ift will be fixed.
 
Manufacturer Narrative
Pentax model ec38-i10f2 is not distributed in the usa, therefore 510k is not applicable.We do have similar model eg36-j10ur-us available in the united states with a 510k number k200090.If any additional information is received, a supplemental report will be submitted.
 
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Brand Name
PENTAX
Type of Device
DIGITAL RADIAL ULTRASOUND SCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12424044
MDR Text Key283310442
Report Number9610877-2021-00797
Device Sequence Number1
Product Code ODG
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,distri
Type of Report Initial
Report Date 09/03/2021
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
Device Operator Health Professional
Device Model NumberEG36-J10UR
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/06/2021
Initial Date FDA Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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