MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM

Model Number	28300BA
Medical Device Problem Codes	Break (1069); Dent in Material (2526); Optical Problem (3001); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: optical breakage during the itv.The surgery had to be postponed and a prolonged hospitalization was required.Therefore, the case 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).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the technical inspection of the returned device, the error description provided by the customer, "optical breakage", could be confirmed.The examined optics show a fracture in the area where the shaft connects to the base housing, which was caused by mechanical overload.Optical components such as glass rod lenses and spacer elements have been ejected from the system tube because of the fracture.In addition, the shaft shows impact marks at the distal end.The distal solder joint has been chemically corroded.The damage found is not attributable to a manufacturing/production defect.The optics were mechanically overloaded, which led to their failure.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.4 MM, 10 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: 23064703
• Report Number: 9610617-2025-01506
• Device Sequence Number: 15915031
• Product Code: HRX
• UDI-Device Identifier: 04048551111628
• UDI-Public: 04048551111628
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K943052
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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: 28300BA
• Device Catalogue Number: 28300BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 11/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/30/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown