MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, Ø 2.7 MM, 11 CM

Model Number	1230AA
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "ent surgeon complained of a burned finger from using the 0-degree scope.Since the description indicates that the surgeon burned a finger, the event is deemed reportable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, Ø 2.7 MM, 11 CM
• Common Device Name: HOPKINS TELESCOPE 0°, Ø 2.7 MM, 11 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23414651
• Report Number: 2020550-2025-01939
• Device Sequence Number: 13364115
• Product Code: EOB
• UDI-Device Identifier: 04048551054291
• UDI-Public: 04048551054291
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/29/2025
• Report Date (Section F): 10/29/2025

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1230AA
• Device Catalogue Number: 1230AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No