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

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).

• Brand Name: CYSTOSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• MDR Report Key: 12161045
• MDR Text Key: 261747372
• Report Number: MW5102508
• Device Sequence Number: 1
• Product Code: FAJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN TO PATIENT
• Device Catalogue Number: UNKNOWN TO PATIENT
• Device Lot Number: UNKNOWN TO PATIENT
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Weight: 78