MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA. INC HOPKINS TELESCOPE 12°, 2.9 MM, 30 CM

Model Number	R26020FA
Medical Device Problem Codes	Device Reprocessing Problem (1091); Corroded (1131); Detachment of Device or Device Component (2907); Material Deformation (2976); Optical Problem (3001); Failure to Clean Adequately (4048); Poor Visibility (4072)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the scope had error message and blurry image that delayed the case for 45 minutes.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the following damage/defects were found during the inspection of the optics: bent shaft, kink in the shaft, incrustations on the distal cover glass, twisted light connection, incrustations/residues on the entire optical surface.The customer's statement scope had error message and blurry image can be confirmed.The imaging of the optics is negatively affected by severe incrustation/adhering residues.Furthermore, the optics shaft is severely bent and has a kink in the middle section.The light connection is loose and cannot be separated from the connection adapter.There are deposits/incrustations of unknown origin on the entire surface of the optics.The condition of the optics can be described as poor.The damage/defects found on the optics are not due to a manufacturing/production error.The damage was caused by clinical use and clinical reprocessing.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 12°, 2.9 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 12°, 2.9 MM, 30 CM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA. INC; 2151 e. grand avenue; el segundo CA 90245
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA
• MDR Report Key: 22321992
• Report Number: 9610617-2025-01093
• Device Sequence Number: 18389356
• Product Code: FAJ
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: R26020FA
• Device Catalogue Number: R26020FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female