MAUDE Adverse Event Report: KARL STORZ ENDOVISION 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL

Model Number	11278A1
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the 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).
Event or Problem Description
According to the information received, image dropouts during procedure observed and a leakage.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Result of investigation: a visual and functional test was carried out on the endoscope.Handgrip, housing and shaft shows slight signs of wear.The vertebrae are fractured approximately 32 mm from the distal end.The angle cover is punctured from the inside.The image bundle shows several fiber breaks.The angulation torsion is outside the tolerance range.The angel cover was cut open during the evaluation.The error described by the customer " image dropouts" could be confirmed.The cause of this error is that the bendable distal section of the endoscope broke due to lateral stress.The break caused the bending joints to shift and the fibers of the image conductor to break.This led to a loss of image from the broken fibers.In addition, a damaged bending joint pierced the angle cover.For this reason, a user misuse error is to be considered which led to the bad image.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 ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23865585
• Report Number: 1221826-2025-02390
• Device Sequence Number: 4618934
• Product Code: FGB
• UDI-Device Identifier: 04048551226339
• UDI-Public: 04048551226339
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/09/2026

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
• Device Catalogue Number: 11278A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2025
• 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: 01/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/09/2026
• 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