MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETERO-RENOSCOPE, 7 FR., 6°, 43 CM

Model Number	27000L
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the uretero-renoscope has a bent shaft and provided no vision during procedure.No negative impact in state of health reported.
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
Investigation: a more detailed investigation into the cause cannot be carried out because, despite several written requests, the optics in question have not been made available to us.Conclusion: the customer's statement "no vision, shaft bent" cannot be confirmed/investigated because the optics in question have not been made available despite multiple written requests.Therefore, it is not possible to investigate to determine the exact cause.According to the customer's description, the shaft is bent, and imaging is no longer possible.The shaft may have been mechanically damaged during clinical use/clinical reprocessing.If the item is made available to us, the report will be reopened, and the cause analysis will be started.No further measures will be taken.The above conducted 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 devices 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.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: URETERO-RENOSCOPE, 7 FR., 6°, 43 CM
• Common Device Name: URETERO-RENOSCOPE, 7 FR., 6°, 43 CM
• 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: 22854020
• Report Number: 9610617-2025-01448
• Device Sequence Number: 11866936
• Product Code: FGB
• UDI-Device Identifier: 04048551311271
• UDI-Public: 04048551311271
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K233372
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 27000L
• Device Catalogue Number: 27000L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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