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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP Back to Search Results
Model Number FI-9RBS
Device Problem Residue After Decontamination (2325)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Manufacturer Narrative
This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the operation channel was clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the ocular cover glass fluid damage, the insertion flexible tube (ift) broken, the segment crushed, the biopsy inlet tpiece worn out, and the light guide fiber bundle (lcb) was broken; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
 
Event Description
The time of event is unknown.There was no report of patient harm.Operation channel clogged.
 
Manufacturer Narrative
This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the operation channel was clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the ocular cover glass fluid damage, the insertion flexible tube (ift) broken, the segment crushed, the biopsy inlet tpiece worn out, and the light guide fiber bundle (lcb) was broken; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
 
Event Description
The time of event is unknown.There was no report of patient harm.Operation channel clogged.
 
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Brand Name
PENTAX
Type of Device
FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishisima-shi, tokyo 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishisima-shi, tokyo 196-0 012
JA   196-0012
Manufacturer Contact
william goeller
3 paragon drive
montvale, NJ 07645
MDR Report Key13091468
MDR Text Key285845424
Report Number9610877-2021-51019
Device Sequence Number1
Product Code CAL
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2021
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-9RBS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Initial Date Manufacturer Received 12/15/2021
Initial Date FDA Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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