MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM

Model Number	11575A
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
The following was reported: "a 54-year-old patient was admitted for a parotid sialendoscopy.After induction of anesthesia, during the equipment check, the sialendoscope was found to be non-functional: there was no visibility on the video column screen (no image), and the optical fibers appeared to be broken.The patient was awakened, and the reprocessing procedure for the second sialendoscope was initiated for urgent sterilization, in preparation for a reintervention later the same afternoon.

• Brand Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM
• Common Device Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 25513148
• Report Number: 2020550-2026-01381
• Device Sequence Number: 21475723
• Product Code: GCJ
• UDI-Device Identifier: 04048551006252
• UDI-Public: 04048551006252
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/15/2026
• Report Date (Section F): 06/15/2026

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: 11575A
• Device Catalogue Number: 11575A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• 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
• Patient Sex: Unknown