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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  Injury  
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
The device referenced in this report has been returned to olympus for evaluation. Physical evaluation of the complaint device reveals: the scope passed the water dunk test. It is confirmed, the rubber glue is cracking/peeling. There are no cracks on the ob lens, the image passed the fog test, there were no stains. The bending section was found to be dry with no looseness of the distal end. There were no cuts of crack on the video cable or connectors. 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 of upon receipt of additional relevant information.
Manufacturer Narrative
This report is being updated to report new and corrected information reported by the customer. Corrected data is reported. New information is reported.
Event Description
Corrected information: this scope is associated with a patient event. New information: there were no black specks found pre-procedure. During the procedure, a black speck was found floating in the bladder. The surgeon removed the back speck with a syringe. One dose of amoxicillin by mouth was given post procedure. The patient has experienced no adverse effects as a result of this occurrence. The patient's current condition is described as: no adverse events at this time.
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
MDR Report Key11957485
MDR Text Key280817705
Report Number8010047-2021-07230
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
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 Manufacturer04/17/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/08/2021 Patient Sequence Number: 1