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U.S. Department of Health and Human Services


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Model Number CYF-VHR
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation. Preliminary findings are reported. Physical evaluation of the complaint device reveals: the rubber glue is cracked. The scope passed the water dunk test. The image has no stain or flicker. All required repairs were completed and the device was shipped back to the customer meeting safety specifications. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event Description
It is reported in mw5101053, after reprocessing a cysto-nephro videoscope, black specks were noted. There is no reported patient contact/impact related to this occurrence. In mw5101053, this facility reports 6 cases. Report with patient identifier (b)(6) reports case 1 of 6. Report with patient identifier (b)(6) reports case 2 of 6. Report with patient identifier (b)(6) reports case 3 of 6. Report with patient identifier (b)(6) reports case 4 of 6. Report with patient identifier (b)(6) reports case 5 of 6. Report with patient identifier (b)(6) reports case 6 of 6.
Manufacturer Narrative
This report is being updated to report corrected information and new information provided by the customer. Corrected data is reported. New information is reported.
Event Description
Corrected information: this scope is associated with a patient procedure new information: the procedure being performed was a cystoscopy for the indication of: benign prostatic hypertrophy (bph) with obstruction, urinary urgency, nocturia, and dysuria. The cystoscopy was completed. Black residual/specks were found on a 4x4 post procedure (pre-cleaning). The 4x4 and scope were sent to sterile processing to look at the scope. The patient has not experienced any adverse effects as a result of this occurrence, and did not require any treatment. The patient's current condition is described as not adverse events noted.
Manufacturer Narrative
This report is being updated to report investigation findings. New information is reported. Device history record (dhr)/service history review: a dhr review has been performed for this product and determined that there were no nonconformance's during the manufacturing process of this device. A review of the instructions for use (ifu) shipped with the device provided the customer with the following information regarding the reported event: chapter 5 troubleshooting 5. 1 troubleshooting warning: never use the endoscope on a patient if an irregularity is observed. Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage. If any parts of the endoscope fall off inside the patient body due to equipment damage or failure, stop using the endoscope immediately and retrieve the parts in an appropriate way. Cyf-vh/vhr reprocessing manual chapter 5 reprocessing the endoscope 5. 5 manually cleaning the endoscope and accessories dry external surfaces 2 inspect the endoscope for residual debris. Should any debris remain, repeat the entire cleaning procedure until all debris is removed. Conclusion: it is presumed that the foreign object, which remained inside the scope, was due to inadequate reprocessing and failure to fully follow the ifu. It was determined the issue was not due to a defect of the device or manufacturing process.
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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 Key11957526
MDR Text Key274001147
Report Number8010047-2021-07232
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VHR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse