MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.; Electrode, Electrosurgical, Active, Urological

Model Number	27294AA
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lens came out from scope during surgery.The vision deteriorated immediately thereafter, and the procedure was completed with another device.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section b5 adn a correction is provided in section d4.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information was provided that the lens popped out of the casing during a percutaneous cystolithotripsy.The vision deteriorated immediately thereafter, and the procedure was completed with another nephroscope.No lens fragments remained inside the patient.Device not returned.
Additional Manufacturer Narrative
Additional information: investigation: an investigation of the optics in question could not be carried out because, despite several written requests for a more detailed analysis of the cause, the optics were not returned to manufacturer.Conclusion: despite several written requests for further analysis of the cause, the optics were not returned to us.Therefore a investigation of the complaint device is not possible and the customer description cannot be confirmed.According to the customer description, the optical lens system suddenly came out of the system tube and the imaging deteriorated immediately.A possible cause for this could be a chemically or mechanically loosened adhesive/solder connection on the distal cover glass, which in turn was caused by faulty processing.No further measures will be taken.No corrective actions necessary as there is no critical and/or systematic deviation found during investigation.However, the customer will be reminded and made aware of correct handling and product testing.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction: d9.Date of investigation: 2026-01-15.Result of investigation: during technical investigation a missing distal cover glass was found and a rod lens system had come loose as a result.Corrosion and adhering residues are visible in the distal area.The distal solder joint has been chemically dissolved.The root cause analysis revealed that the distal solder seam was missing due to chemical influences.The distal cover glass is missing, and the rod lens system has come out of the system tube due to the missing cover glass.Furthermore, unknown residues and corrosion are visible on the distal end.The damage is not due to a manufacturing/production defect.A missing/dissolved distal solder seam indicates faulty processing.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°, 18 FR.
• Common Device Name: Electrode, Electrosurgical, Active, Urological
• 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
• MDR Report Key: 22287966
• Report Number: 9610617-2025-01060
• Device Sequence Number: 12855616
• Product Code: FAS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 27294AA
• Device Catalogue Number: 27294AA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 10/14/2025; 01/15/2025; 09/04/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/24/2025; 10/15/2025; 02/09/2026; 09/30/2026
• 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