MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.

Model Number	27294AA
Medical Device Problem Codes	Optical Problem (3001); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device shows blurred vision.According to the information received the duration of the surgical prolongation was therefore longer than 60 minutes and the procedure was not completed successfully.In addition, an additional surgical/medical or diagnostical intervention was necessary to prevent further injury to the patient and an additional or prolonged hospitalization was necessary.Therefore, the risk to cause or contribute to a death or serious injury is not negligible and the event is deemed reportable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Update to section b5, patient health status.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The patient presented for left pcnl for renal pelvis and lower calyx stone.Surgery was scheduled for 1.5 to 2 hours, the surgery was prolonged for 1 hour.The issue occurred intra-operatively during the stone fragmentation.Due to the blurred vision, the surgeon was unable to fully remove the stone.The remaining stone will be addressed in a follow-up pcnl.Patient will require a second pcnl surgery to remove the remaining stone.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.Additional information also added in section h4.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: a precise error analysis regarding the customer description cannot be carried out because the aforementioned optics have not been made available to manufacturer despite multiple written requests.A root cause analysis is not possible.A possible cause of the fault could be mechanical damage to the imaging system or an imaging component.Furthermore, damage caused by improper/incorrect clinical reprocessing could be responsible for the defect in the optics.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: HOPKINS TELESCOPE 6°, 18 FR.
• 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, CA 90245
• MDR Report Key: 22773434
• Report Number: 9610617-2025-01384
• Device Sequence Number: 9341740
• Product Code: FGA
• UDI-Device Identifier: 04048551233825
• UDI-Public: 04048551233825
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K232370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2025

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: Health Professional
• Device Model Number: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/19/2025; 10/14/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/30/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown