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

Model Number	27005BA
Medical Device Problem Codes	Optical Obstruction (3002); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
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).
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
Additional information: as the device in question was not returned by the customer, a physical examination of the product could not be conducted.Nevertheless, all available information has been thoroughly reviewed.Based on an investigation of the reported malfunction conducted in japan, it has been determined that the root cause is attributable to user-related factors.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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24552823
• Report Number: 9610617-2026-00498
• Device Sequence Number: 15799319
• Product Code: FAJ
• UDI-Device Identifier: 04048551001066
• UDI-Public: 04048551001066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K243653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown