MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 70°, 4 MM, 18 CM

Model Number	7230CWA
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that optics do not allow viewing image.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Device evaluation: the customer's information "optics do not allow viewing image" can be confirmed.A bent shaft was found when the optics were examined.The shaft is bent directly after the connection cone.The bent shaft resulted in a broken rod lens, which means that imaging is no longer possible.The distal solder seam is slightly chemically affected but intact.The optic was disassembled to confirm and document the rod lens breakage.The damage found may have been caused during clinical use or during clinical reprocessing and cannot be attributed to a manufacturing/production defect.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 70°, 4 MM, 18 CM
• Common Device Name: HOPKINS TELESCOPE 70°, 4 MM, 18 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 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: 22004536
• Report Number: 9610617-2025-00821
• Device Sequence Number: 13109064
• Product Code: EOB
• UDI-Device Identifier: 04048551193976
• UDI-Public: 04048551193976
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K945788
• 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): 06/18/2025

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: 7230CWA
• Device Catalogue Number: 7230CWA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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