MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 5 MM, 29 CM

Model Number	R26046AA
Medical Device Problem Codes	Optical Problem (3001); No Apparent Adverse Event (3189)
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 manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported the scope has blurry image.No harm or injury to patient reported.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correction in section g4 correct -510k was added k935279.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device was sent to the karl storz service department for inspection.During the technical inspection, the error description provided by the customer, " the scope has blurry image ", could not be confirmed.The examination did not reveal any negative image in relation to the customer's specifications.The image is clear and sharply defined and shows very good depth of field.When focusing on the individual rod lens sections, isolated foreign particles are visible in the blurred area of the optics, but these have no negative impact on the imaging.Furthermore, an impact mark at the distal end and chemical damage to the distal solder seam can be seen.The foreign particles detected may have been introduced into the system during the production of the optics, but as mentioned above, they have no negative impact on imaging.The chemical damage detected and the mechanical damage at the distal end are attributable to clinical reprocessing or clinical use.The above investigations did not reveal a root cause related to the labelling, the device, or its history.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 id (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• 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: 22036394
• Report Number: 9610617-2025-00872
• Device Sequence Number: 8177896
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 04048551092088
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K935279
• 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,Followup
• Report Date (Section B): 12/19/2025

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: R26046AA
• Device Catalogue Number: R26046AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided; 12/08/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/28/2025; 12/19/2025
• 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