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Model Number TJF-Q180V
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for evaluation.There was leaking noted between the control body and the bending section cover.There were also, dents and scratches noted on the control body.A portion of the bending section rubber was found missing and the bending section glue was noted to be cracked on the bending section cover and insertion tube.Further inspection found the light guide lens was dirt and chipped.The objective lens had old glue.The elevator lever showed signs of corrosion/discoloration.The instruction manual provides warnings to prevent damage to the endoscope and how to ensure to inspect the elevator lever.Do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Inspect the forceps elevator and the area which can be visually accessible in elevator recess, while raising and lowering the forceps elevator to confirm that there is not any foreign materials, such as debris and fluids, but not limited to.If any foreign materials is observed, stop using the endoscope and take necessary measures according to section 6.2, ¿inspection before each patient procedure¿ on page 74.
Event Description
The service center was informed that the scope improperly reprocessed as the scope cleaning was delayed.There was no patient involvement reported.
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the contents of this complaint.As the results of the dhr review, it was confirmed that the subject scope was shipped in accordance with specifications.The legal manufacturer reported that the most probably cause for the reported events are as follow: phenomenon: gap of adhesive on the distal end / stain entered inside the lens through the gap.The legal manufacturer reported that the event may have occurred by physical stress and/or chemical stress.It may also have been due to poor environment of storing (direct rays of the sun, too hot, highly humid, exposed to x-ray/ultra violet ray, etc.) and/or deterioration by aging, as well.Phenomenon: inspection requested after delayed reprocessing.The cause of the event cannot be conclusively determined.The legal manufacturer would like the user to perform immediate reprocessing after use, in accordance with ifu.
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Brand Name
Type of Device
Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
MDR Report Key10708510
MDR Text Key224663653
Report Number8010047-2020-07916
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/18/2020
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 NumberTJF-Q180V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/20/2020
Supplement Dates Manufacturer Received11/19/2020
Supplement Dates FDA Received12/18/2020
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 Reuse
Patient Sequence Number1