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Model Number CYF-V2
Device Problems Particulates (1451); Scratched Material (3020)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. The user¿s complaint of black flecks coming out of the scope was confirmed. The device was visually inspected and found the scope has black particles at the distal tip. The scope failed the water dunk test and is leaking from the instrument channel. The channel was verified with proscope and saw multiple tear marks and excessive tear marks near biopsy port. There were chip marks/peeling on the bending section cover glue from the distal end and insertion tube sides. The bending section cover glue has evidence of scratches, which most probably caused the cement to chip off. The peeling off pieces of the bending section cover glue were not returned for evaluation. Also found switch #3 was not working and there was a crack on the video connector. The listed parts were replaced. The device is fully functional and returned to the user facility.
Event Description
The user facility reported that there was an issue with the device. The device had foreign material falling off from the channel. It was like metal coming out of it like little flecks. This event happened during the end of a therapeutic procedure. The procedure was completed with an alternate device. The flecks were very small less than 1mm. The flecks entered the bladder and the patient was allowed to void them out. There was no patient injury or harm. No additional information was provided.
Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review. Updates to sections. The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications. The legal manufacturer performed an investigation. A conclusive root cause was not identified. The legal manufacturer determined the likely cause of the reported problem of "foreign material falling off from the channel" as follows: it is inferred, based on the result of the device evaluation and the available information, that the material in the insertion section tube penetrated because the forceps channel was perforated by a "treatment instrument. " based on the result of the legal manufacturer's investigation and device evaluation results, the likely cause of the event can be attributed to user handling and/or technique. As stated in the instructions for use, as a preventive measure: "if an endotherapy accessory cannot be withdrawn from the endoscope, close the tip of the endotherapy accessory or retract the tip of the endotherapy accessory into its sheath and slowly withdraw the endoscope while observing the endoscopic image. Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and/or cause patient injury. " "if the insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image. Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories, cause some parts to fall off and/or cause patient injury. ".
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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 Key10670538
MDR Text Key223663006
Report Number8010047-2020-07616
Device Sequence Number1
Product Code FAJ
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse