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

Model Number	R27005CA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 had foggy/damaged lens.No patient involvement.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Result of investigation: during the technical inspection, the error description provided by the customer, foggy, could be confirmed.The reported issue damaged lense could not be confirmed.The root cause analysis revealed a chemically corroded and damaged distal solder joint.In addition, additional wear is visible in the rod system, which is attributable to use.Furthermore, residues are visible on the distal cover glass, which, together with the heavy abrasion in the rod lens system, have a negative impact on imaging.No broken rod lenses as reported by customers could be found.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 70°, 4 MM
• Common Device Name: HOPKINS TELESCOPE 70°, 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: 23514637
• Report Number: 9610617-2025-02011
• Device Sequence Number: 9955598
• Product Code: FAJ
• UDI-Device Identifier: 04048551001073
• UDI-Public: 04048551001073
• 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): 03/27/2026

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
• Device Model Number: R27005CA
• Device Catalogue Number: R27005CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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 Sex: Unknown