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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS FLEXIBLE HD CYSTOSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
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OLYMPUS CORPORATION OF THE AMERICAS FLEXIBLE HD CYSTOSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM Back to Search Results
Model Number CYF-VHR
Device Problems Structural Problem (2506); Contamination /Decontamination Problem (2895); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Multiple olympus cystoscopes, cyf-vhr, have intra-luminal fibers, develop inside the lumen with minimal use.This was discovered on borescope inspection before and after cleaning.This caused the scopes to be pulled from service, sent out for repair and caused patient treatment delays d/t limited scopes on site.Several thousands of dollars spent on increasing scope inventory and repair bills from olympus (which does not always fix the issue).The fibers sticking out from the lumen can pose a risk of cross contamination to the next patient.Fiber protruding into lumen can cause improper cleaning of scope lumen.Also pose a risk of dislodging into a patient, or causing tearing in the lumen if snagged.We have sent out several scopes for repair since summer of last year.
 
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Brand Name
FLEXIBLE HD CYSTOSCOPE
Type of Device
ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
MDR Report Key16832634
MDR Text Key314268320
Report NumberMW5117092
Device Sequence Number1
Product Code NWB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/21/2023
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 NumberCYF-VHR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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