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

Model Number	11278A1
Medical Device Problem Codes	Optical Obstruction (3002); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: there's air leakage happening, and the working channel is clogged.The deflection is either insufficient.No information about patient injury and no negative impact in state of health reported.
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
Result of investigation: the endoscope was tested after production with the insp.Lot 40000694503 and the endoscope passed this test.The examination revealed that the shaft was bent by external force.As a result, the working channel is also kinked and no longer passable.Several fibers of the image bundle are also broken.The kink in the shaft also impairs angulation.Obviously, the endoscope was not handled with the necessary care as described in detail in the instructions for use under point 8.The damage found is not due to a manufacturing/production defect but is the result of mechanical damage during use or clinical reprocessing.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 ; GM 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21334637
• Report Number: 1221826-2025-00161
• Device Sequence Number: 3849441
• Product Code: FGB
• UDI-Device Identifier: 04048551226339
• UDI-Public: 04048551226339
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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
• Device Lot Number: 2270260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown