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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP Back to Search Results
Model Number FI-10RBS
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
On 2021/10/14 when i checked the scope of (b)(6) heart center who received repairs at (b)(4), it was registered with fi-10rbs, s / n: (b)(4) in (b)(4), but the inscription of the actual product is fi-10bs, it was s / n: (b)(4).This event occurred at the time of before delivery.There was no report of patient harm.
 
Manufacturer Narrative
Evaluation summary: although the production of fi-10bs was completed in 2016, the 2018 manufacturing year inscription was affixed, so when i checked with the (b)(4) plant, it was said that the model inscription was erroneously affixed.This device is not marketed in us, therefore 510k is not applicable.
 
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Brand Name
PENTAX
Type of Device
FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12749745
MDR Text Key284699789
Report Number9610877-2021-01358
Device Sequence Number1
Product Code CAL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 11/03/2021
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 NumberFI-10RBS
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/15/2021
Initial Date FDA Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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