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

Model Number	26105BA
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported the rod lens of four hysteroscopes has already broken 4 times.Unfortunately, there is no longer sufficient visibility to operate.No death or unanticipated serious deterioration in state of health reported.Cross reference mdr: 9610617-2025-00131.9610617-2025-00132.9610617-2025-00134.
Additional Manufacturer Narrative
Device evaluation: the information provided by the customer cannot be verified at this time, as the affected optics have not been made available for detailed inspection.A review of internal records revealed no trend or increased frequency of rod lens breakages for the hysteroscope model in question.Based on similar cases and product design knowledge, the most probable cause of rod lens breakage is typically mechanical overload, which may occur during: clinical use.Handling or transportation.Reprocessing, especially during manual cleaning, drying, or sterilization there is no indication of a manufacturing or production defect based solely on the customer's description.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 4 MM, 30 CM
• Common Device Name: RIGID OPTICAL HYSTEROSCOPE
• 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: 21318172
• Report Number: 9610617-2025-00133
• Device Sequence Number: 15486049
• Product Code: HIH
• UDI-Device Identifier: 04048551093597
• UDI-Public: 04048551093597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K223885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26105BA
• Device Catalogue Number: 26105BA
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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
• Patient Sex: Unknown