MAUDE Adverse Event Report: KARL STORZ SE & CO.KG GREENLIGHT HOPKINS TELESCOPE 30°, 4 MM

Model Number	R27005BGA
Medical Device Problem Codes	Device Reprocessing Problem (1091); Optical Distortion (3000); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further 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 has been reported the scope was cloudy.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the device was sent to the karl storz assessment and repair department for inspection.During the technical inspection, the error description provided by the customer, "cloudy", could be confirmed.During the examination of the optics, an unknown coating was found on the distal cover glass, which can be removed mechanically.The adhering residue has a negative effect on the image quality.Furthermore, minimal residues are visible in the negative area of the rod lens system, but these do not have a negative impact on the image quality.The distal solder seam is corroded.The residue on the distal cover glass can be removed mechanically.The damage/defects found are due to normal use/wear and tear or inadequate clinical reprocessing.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.This event is filed under internal complaint (b)(4).

• Brand Name: GREENLIGHT HOPKINS TELESCOPE 30°, 4 MM
• Common Device Name: GREENLIGHT HOPKINS TELESCOPE 30°, 4 MM
• Manufacturer (Section D): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• 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 90245 ; 4242188247
• MDR Report Key: 23606682
• Report Number: 9610617-2025-02130
• Device Sequence Number: 21133239
• Product Code: FAJ
• UDI-Device Identifier: 04048551288740
• UDI-Public: 04048551288740
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/17/2026

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: R27005BGA
• Device Catalogue Number: R27005BGA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/17/2026
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 97 KG