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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP Back to Search Results
Model Number FCY-15RBS
Device Problems Fracture (1260); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: it was caused due to an excessive force applied on the instrument channel inlet. In addition, we confirmed that the forward body cover break; however, it is not related to the alleged complaint. This device is classified as import for export, therefore 510k is not applicable. This report is being filed as part of the pentax backlog management plan.
 
Event Description
(b)(6) 2021 i noticed that the forceps opening was loose during cleaning the day before and contacted me. Replaced with a substitute because the forceps opening is loose as before. Repair custody. Regarding the confirmation of the installation of the t-shaped tube, it is said that it has already been known that the installation of the t-shaped tube was explained at the previous visit. It is said that other manufacturers can not know the same thing. Borrow the t-shaped tube used this time for verification. This event occurred at the time of reprocessing. There was no report of patient harm.
 
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Brand NamePENTAX
Type of DeviceFIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA 196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA 196-0012
Manufacturer Contact
william goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key12200847
MDR Text Key263397191
Report Number9610877-2021-10284
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFCY-15RBS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
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

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