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

Model Number	11278VS
Medical Device Problem Codes	No Display/Image (1183); Temperature Problem (3022)
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 leaky working channel, no image.No negative impact in state of health reported.
Additional Manufacturer Narrative
A visual and functional test was carried out on the endoscope.The housing and handle show signs of wear.The shaft is squeezed.The distal tip is damaged by laser, the ceramic sleeve is broken and the working channel is leaking.The angulation is outside the tolerance range.The image and light output from the endoscope are in order.Tested with tc301 sn (b)(6) and tm263 sn (b)(6).The angel cover was cut open during the evaluation.The error described by the customer " no image" could not be confirmed.It is highly likely that moisture has penetrated the endoscope through the leaky working channel, causing a short circuit on the chip and resulting in image failure.After some time, the moisture will evaporate, and the image will be displayed again.The reason for the moisture ingress is the leaky working channel damaged by the laser.For this reason, it can be assumed that a user error occurred when activating the laser, which led to the temporary image failure.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.The complaint history did not reveal any pickup in similar complaints no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
A visual and functional test was carried out on the endoscope.The housing and handle show signs of wear.The shaft is squeezed.The distal tip is damaged by laser, the ceramic sleeve is broken and the working channel is leaking.The angulation is outside the tolerance range.The image and light output from the endoscope are in order.Tested with tc301 sn (b)(6) and tm263 sn (b)(6).The angel cover was cut open during the evaluation.The error described by the customer " no image" could not be confirmed.It is highly likely that moisture has penetrated the endoscope through the leaky working channel, causing a short circuit on the chip and resulting in image failure.After some time, the moisture will evaporate, and the image will be displayed again.The reason for the moisture ingress is the leaky working channel damaged by the laser.For this reason, it can be assumed that a user error occurred when activating the laser, which led to the temporary image failure.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.The complaint history did not reveal any pickup in similar complaints no trend was identified.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: 23991564
• Report Number: 1221826-2026-00006
• Device Sequence Number: 10398535
• 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): 03/04/2026

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: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 02/23/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/24/2026; 03/04/2026
• 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