MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB

Model Number	20133620-133
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a turbt procedure on (b)(6) 2025, the urologist was using blue light to take tissue samples to confirm if the patient required a cystectomy or not.The urologist resected using white light but was not able to use the blue light technology to confirm he had removed all of the cis (carcinoma in situ).He did try to get a biopsy where he thought he saw the illumination as the light worked the first time, he active the blue light but didn't for the additional attempts.After he biopsied, he went on to resect the bladder.
Additional Manufacturer Narrative
The device was returned to our canadian facility, and will later 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 complaint id (b)(4).

• Brand Name: COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB
• Common Device Name: COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 22667666
• Report Number: 2020550-2025-01315
• Device Sequence Number: 7449516
• Product Code: OAY
• UDI-Device Identifier: 04048551004654
• UDI-Public: 04048551004654
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025
• Report Date (Section F): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20133620-133
• Device Catalogue Number: 20133620-133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male