MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 12°, 2.9MM

Model Number	27020FA
Medical Device Problem Codes	Fogging (1253); Optical Obstruction (3002)
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
It was reported that the vision is foggy.No patient involvement and no negative impact in state of health reported.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: reported issue: foggy vision.Investigation: this optic has a broken rod lens due to a bent stem.The imaging is cloudy and blurred due to the rod lens fracture.No further damage can be detected.Damage identified by the service evaluation: - bent shaft.- broken rod lens, consequential damage due bent shaft.Conclusion: regarding the customer's description, "foggy vision" can be confirmed.The imaging is cloudy and blurred.The cause of the poor imaging is a bent shaft due to excessive mechanical force, which resulted in a rod lens break.No further image-impairing damage can be detected.The distal soldering seam is in very good condition and intact.Except for the mechanically caused damage, the optics are in good condition.The detected damage cannot be attributed to a manufacturing/production defect.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 12°, 2.9MM
• Common Device Name: HOPKINS TELESCOPE 12°, 2.9MM
• 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: 21537907
• Report Number: 9610617-2025-00377
• Device Sequence Number: 7735448
• Product Code: FAJ
• UDI-Device Identifier: 04048551073582
• UDI-Public: 04048551073582
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K943176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 27020FA
• Device Catalogue Number: 27020FA
• Device Lot Number: 1202RZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: Not provided; 05/22/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/17/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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