MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

Model Number	26120BA
Medical Device Problem Codes	Poor Quality Image (1408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "the uterine office hysteroscope model 26120ba performs poorly when in use.The hysteroscope has crystal fracture and blurred image".No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information: conclusion and root cause determination the device was not sent to the karl storz assessment and repair department for inspection.The error description provided by the customer, "crystal fracture and blurred image", could not be confirmed.A precise analysis of the cause cannot be carried out because the optic mentioned is not available to us for closer examination.Based on the customer's information, one possible cause could be mechanical damage (broken rod lens).A break in the rod lenses can be caused, for example, by mechanical stress (impact, shock, or excessive bending of the shaft).If the item is still made available to us, the report will be reopened, and a cause analysis will be carried out.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.9 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: 24491914
• Report Number: 9610617-2026-00410
• Device Sequence Number: 10676754
• Product Code: HIH
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 26120BA
• Device Catalogue Number: 26120BA
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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
• Patient Sex: Unknown