MAUDE Adverse Event Report: KARL STORZ ENDOVISION CYSTO-URETHRO-FIBERSCOPE

Model Number	11272C1
Medical Device Problem Codes	Fracture (1260); Chemical Problem (2893)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shows a broken sheath.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned 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
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description broken sheath was not confirmed.The following damages were found during visual and functional investigation: ---the shafts marking rings are brownish discolored.---the sheathing of the shaft is brittle and torn in several places.---the housing and the handle show slight signs of wear.The checklist provided by customer was double checked and evaluated.Due to the damages found and the evaluation of the checklist it can be determined that the reason for the burst shaft is due to non-compliant reprocessing.The failure can be traced back to a user/reprocessing error.The device passed the quality check at the time of delivery.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information was provided that there was the issue was identified following sterilization procedure and not during the procedure.The broken part does not exist as the sheath was corroded and torn.There was no patient involvment in this event.

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Common Device Name: CYSTO-URETHRO-FIBERSCOPE
• 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
• MDR Report Key: 22717911
• Report Number: 1221826-2025-01364
• Device Sequence Number: 18544613
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 04048551226100
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K945185
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 10/27/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/03/2025; 11/18/2025
• 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