MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL

Model Number	11278A1-X
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during ureteroscopy, the angled guidewire appeared to break while being manipulated over the guidewire.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
The device in question was returned to manufacturer.This information is reflected in section d9.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
Investigation: the fault described by the customer, "suspected breakage of steering wire," was confirmed.The cause of the steering wire breakage at the customer's site was that the solder joint between the steering wire and the cable lugs had come loose.This defect resulted in a disconnection between the lever mechanism and the distal tip.Inspection of both the transmission cable and the cable lugs revealed no signs of defective solder joints or manufacturing defects that could have contributed to the defect.Although the customer stated that no excessive force was applied, this does not rule out the possibility that application technique or handling prior to the incident may have been a contributing factor.A two-year review of service trend data for the 11278a1 models revealed no other cases in which the transmission cable was identified as a contributing factor to a reported loss of deflection.Based on this trend analysis, the incident described in this complaint is considered an isolated case and does not warrant further action at this time.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL
• Common Device Name: 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL
• 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: 23890606
• Report Number: 1221826-2025-02466
• Device Sequence Number: 9297142
• Product Code: FGB
• UDI-Device Identifier: 04048551226339
• UDI-Public: 04048551226339
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982905
• 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): 02/16/2026

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: 11278A1-X
• Device Catalogue Number: 11278A1-X
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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