MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO URETERO-RENOSCOPE FLEX-XC1

Model Number	091271-06
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
According to the information received, when connected to the control unit, it did not give any signal immediately, even after restarting the control unit and several reconnection attempts.No death or (unanticipated) serious deterioration 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
The device in question was returned to the manufacturer.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
Device evaluation: the customer complaint of no image can be confirmed.During the investigation, a loose electrical connector inside the handle was detected.This disengaged connector was identified as the direct cause of the missing image, as it interrupted the signal transmission.Notably, the endoscope had passed several in process tests during manufacturing, all of which require a functional signal output.In addition, visible marks were found on the contacts of the connector plug, indicating that the connector had been mounted.The exact reason for the connector becoming disengaged after these tests could not be clearly determined during the investigation.It is an isolated event.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Common Device Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• 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: 23021611
• Report Number: 9610617-2025-01578
• Device Sequence Number: 13148287
• Product Code: FGB
• UDI-Device Identifier: 04048551428009
• UDI-Public: 04048551428009
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K212458
• 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,Followup
• Report Date (Section B): 04/21/2026

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: 091271-06
• Device Catalogue Number: 091271-06
• Device Lot Number: 500123834
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 04/08/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/09/2025; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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