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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION ACCESS SHEATH CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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OLYMPUS MEDICAL SYSTEMS CORPORATION ACCESS SHEATH CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  Injury  
Event Description
Beak of cystoscope fractured. Fda safety report id #: (b)(4).
 
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Brand NameACCESS SHEATH
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
MDR Report Key11892995
MDR Text Key253124996
Report NumberMW5101557
Device Sequence Number1
Product Code FAJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/26/2021 Patient Sequence Number: 1
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