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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS CYSTOSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
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OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS CYSTOSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM Back to Search Results
Model Number CYF-VHR
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
Event Type  Injury  
Event Description
In preparation, final magnified lighted inspection of olympus cystoscope cyf-vhr, s/n (b)(4) was noted to have chipping of the adhesive on the distal tip section.Investigation of uses determined the scope to be at 18 cycles; these were received (b)(6) 2021 after previous incidents with cystoscopes and contract with olympus.No patients were involved.Immediate notification was made to adpcs, biomed and visn lead.Work order was placed and the scope was sent out for repair.Olympus repair/work performed report received (b)(6) 2022 noted: bending sect.Distal tip file and reglue.The adhesive at the bending cover is prepared and cleaned.An olympus proprietary adhesive is applied to the bending cover at the distal end.The adhesive is tested to ensure that the diameter and condition of the adhesive meets olympus specifications.The endoscope is tested to ensure watertight integrity.Fda safety report id # (b)(4).
 
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Brand Name
OLYMPUS CYSTOSCOPE
Type of Device
ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
MDR Report Key13505944
MDR Text Key285466514
Report NumberMW5107345
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 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
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 Manufacturer01/28/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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