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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number UNKNOWN TO PATIENT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Sepsis (2067); Chills (2191); Malaise (2359)
Event Date 12/14/2020
Event Type  Injury  
Event Description
Approximately 24 hours after cystoscopy i started running fever, chills and feeling bad all over went to hospital and was admitted with sepsis. On or about (b)(6) 2021 it was brought to my attention that the "fda is investigating reports of infections associated with reprocessed urological endoscopes" found at this url https://www. Fda. Gov/news-events/press-announcements/fda-investigating-reports-infections-associated-reprocessed-urologicalendoscopes? utm_medium
=
email&utm_source
=
govdelivery. Original test result available upon request. Assessment comment: severe sepsis secondary to uti vs prostatitis. Fda safety report id# (b)(4).
 
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Brand NameCYSTOSCOPE
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
MDR Report Key12161045
MDR Text Key261747372
Report NumberMW5102508
Device Sequence Number1
Product Code FAJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN TO PATIENT
Device Catalogue NumberUNKNOWN TO PATIENT
Device Lot NumberUNKNOWN TO PATIENT
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: 07/12/2021 Patient Sequence Number: 1
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