MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. STORZ FLEXIBLE CYSTOSCOPE; CYSTOURETHROSCOPE

Model Number 11272CU1

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Bacterial Infection (1735)

Event Date 08/08/2022

Event Type  Injury  

Event Description

Pseudomonas infection after cystoscope exam t symed, (b)(6) which resulted in hospitalization at shane's hospital for 3 days with iv of cipremin followed by 7 days of picc line treatment with home health.Fda safety report id# (b)(4).

• Brand Name: STORZ FLEXIBLE CYSTOSCOPE
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.
• MDR Report Key: 15418471
• MDR Text Key: 299942528
• Report Number: MW5112004
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11272CU1
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White