MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.

Model Number	27294AA
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device shows blurred vision.According to the information received, the duration of the surgical prolongation was therefore longer than 60 minutes and the procedure was not completed successfully.In addition, an additional surgical/medical or diagnostical intervention was necessary to prevent further injury to the patient and an additional or prolonged hospitalization was necessary.Therefore, the risk to cause or contribute to a death or serious injury is not negligible and the event is deemed reportable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°, 18 FR.
• Common Device Name: HOPKINS TELESCOPE 6°, 18 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22773430
• Report Number: 2020550-2025-01384
• Device Sequence Number: 18477022
• Product Code: FGA
• UDI-Device Identifier: 04048551233825
• UDI-Public: 04048551233825
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/11/2025
• Report Date (Section F): 08/11/2025

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: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• 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; Hospitalization
• Patient Sex: Unknown