MAUDE Adverse Event Report: KARL STORZ ENDOVISION CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW®

Model Number 11272VUEK

Device Problem Microbial Contamination of Device (2303)

Patient Problem Urinary Tract Infection (2120)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case (b)(4).

Event Description

It was reported that the patient developed uti infection after completion of a procedure.No patient impact was reported at the time of the completion of the procedure.The doctor notified us after he found out that the patient developed uti infection post op.According to the doctor, patient was then given antibiotics, and is doing fine now.

• Brand Name: CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW®
• Type of Device: CYSTO-URETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 18976345
• MDR Text Key: 338550138
• Report Number: 2020550-2024-00083
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04048551431405
• UDI-Public: 4048551431405
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11272VUEK
• Device Catalogue Number: 11272VUEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 102 KG