MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 10 MM, 31 CM

Model Number	26003BA
Medical Device Problem Codes	Image Display Error/Artifact (1304); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, optics is unclear.No information about patient involvement available.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the customer's statement "optics blurry" can be confirmed.Upon inspection of the imaging, significant blurring and partial defocusing are visible.Severe abrasion is visible in the rod lens system and behind the distal cover glass.The optics may have been pre-cleaned using ultrasound, which led to increased abrasion in the system.Furthermore, the silicone separating layer in the distal cover glass has partially detached and is significantly contributing to the impaired imaging.Due to its age (10 years), the optics also show normal signs of wear.Despite the age of the optics, they are in good overall condition.The damage found is due to wear and tear on the one hand and clinical use/clinical reprocessing on the other.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 10 MM, 31 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 10 MM, 31 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: 21935963
• Report Number: 9610617-2025-00738
• Device Sequence Number: 7985158
• Product Code: GCJ
• UDI-Device Identifier: 04048551090473
• UDI-Public: 04048551090473
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K223923
• 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): 07/21/2025

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: 26003BA
• Device Catalogue Number: 26003BA
• Device Lot Number: 1217HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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
• Patient Sex: Unknown