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

Model Number	11278VS
Medical Device Problem Codes	Use of Device Problem (1670); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, a blocked instrument channel was observed.The customer has confirmed that this was reported in error and that no patient incident occurred.There is no information that the event caused a harm or serious injury to patient, user or third.
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: a visual and functional test was carried out on the endoscope.The handle shows slight signs of wear but no defects found.The error described by the customer "blocked instrument channel" could not be confirmed.The patency of the working channel was tested in accordance with the inspection plan using the clamp 11161mb (system testing) and the cleaning brush 27651al (retour testing pm:71924).No problems were found.In addition, the patency of the working channel was also checked with the cleaning brush 110931-01, lot: 230815, (single use).No problems were found here either.Possible causes for the error reported by the customer could be that the accessories used by the customer were damaged or too large.No faults were detected on the endoscope.For this reason, a user misuse error is to be concluded which led to the customer complaint description.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 ENDOSCOPY; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOSCOPY; 91 carpenter hill road; charlton MH 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22419051
• Report Number: 1221826-2025-01114
• Device Sequence Number: 8680212
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 04048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 08/28/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/25/2025; 09/19/2025
• 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