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

Model Number	11278VS
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device has no picture / no light.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
*correction to h6 the event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation results: the device in question (11278vs, video-uretero-renoskop flex-xc, sn: (b)(6)) was received by the manufacturing site in germany on 17-jul-2025 for investigation.A visual and functional test was carried out on the endoscope.The endoscope shows signs of wear on the handle, distal end and shaft.The angle cover is worn and incised and therefore leaking.The shaft is kinked under the kink protection.The distal end is thermally damaged.The angulation is out of tolerance.No image and light output from the endoscope.Tested with tc301 sn (b)(6) and tm263 sn (b)(6).The housing is filled with moisture and the interface board is corroded.The angel cover was cut open during the evaluation.The error described by the customer "electronics no picture / no light" could be confirmed.The cause was moisture ingress through the angle cover, which damaged the interface board.For this reason, a user misuse error is to be assumed which led to the missing image.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.In addition, we want to draw your attention to page 16 of the corresponding instruction for use (document id: (b)(4)) which includes warnings under section 6.1 "inspecting the product": the flexible endoscope can be damaged by incorrect handling during use.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
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22816349
• Report Number: 1221826-2025-01428
• Device Sequence Number: 18395770
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 04048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 11278VS
• Device Catalogue Number: 11278VS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 02/20/2026; 03/23/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 03/17/2026; 03/24/2026
• 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