MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 4 MM, 30 CM

Model Number	27005BA
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, during surgery, the product's field of view was obscured, rendering it unusable.Although anesthesia was administered, the procedure could not be performed, necessitating a rescheduled surgery at a later date.No death or (unanticipated) serious deterioration in state of health reported.Due to the abortion and postponement of the procedure after the patient was already under anesthesia, the case 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 30°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 4 MM, 30 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24552789
• Report Number: 2020550-2026-00498
• Device Sequence Number: 15762975
• Product Code: FAJ
• UDI-Device Identifier: 04048551001066
• UDI-Public: 04048551001066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/09/2026
• Report Date (Section F): 03/09/2026

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: 27005BA
• Device Catalogue Number: 27005BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• 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