MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO-URETERO-RENOSCOPE FLEX XC

Model Number	11278VS
Medical Device Problem Code	Optical Problem (3001)
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
It was reported that the distal rubber cover is leaky and ccd/cmqs: no image.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: a visual and functional test was carried out on the endoscope.The handle and housing show signs of wear and scratches.The shaft is kinked, the angle cover is leaking, causing moisture to enter the housing.The interface board and the sensor are damaged by moisture residue.The error described by the customer " leaking and no image" could be confirmed.This was caused by moisture ingress, which damaged the sensor and the interface board.Moisture has penetrated the endoscope through the loosen the connection between the angle cover and the head.The connection was loosened by external mechanical forces.For this reason, a user misuse error is to be assumed which led to the missing image.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Common Device Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• 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 ; GM 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22124846
• Report Number: 1221826-2025-00900
• Device Sequence Number: 7273488
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 04048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141250
• 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): 07/08/2025

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: 11278VS
• Device Catalogue Number: 11278VS
• Device Lot Number: 54903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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