MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE VIDEO CYSTO HD-VIEW, SCOPE ONLY

Model Number	11272VH
Medical Device Problem Codes	Degraded (1153); No Display/Image (1183); Defective Component (2292)
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 manufacturer on april 22, 2025.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
The following was reported "insertion shaft, electronics casing brittle, no image ".No negative impact in state of health reported.
Additional Manufacturer Narrative
During the technical inspection of the returned product, the following was found: the error described by the customer " no image" could be confirmed.A visual and functional test was carried out on the endoscope.The endoscope shows signs of use such as wear, scratches, and discoloration.The material of the outer layer of the shaft is cracked.The adhesive bond of the distal tip sleeve is leaking.Rivets on the vertebrae are broken and the angulation is restricted.No image output from the endoscope.The endoscope bending section (vertebrae) is damaged, by excessive mechanical force, due to abnormal use.This damage caused the sensor at the distal end to be damaged, and no image could be transmitted the most probable root cause is due to usage errors.The labelling was found to contain adequate instructions and warnings e.G.Ifu 96136030d, version v1.1_11-2022 (dis 300000272400) notes on page 11, 12, 13, 14, 21, 27 and 46: note: do not hit the distal tip of the flexible videoscope against hard objects, and never use a sharp object to remove dirt.Note: never place heavy objects on the flexible videoscope.Note: never clamp or fold the sheath of the flexible videoscope.This can result in damage to the videoscope.Note: the flexible videoscope must not be carried by the sheath.Do not pull, clamp or twist the sheath of the videoscope.Note: the sheath of the flexible videoscope must never be clamped or coiled up too tightly.It is best to store the video videoscope in a suspended position or to keep it sterilized in a tray specifically designed for sterilizing and storage (39406as).Warning: risk of injury: if the distal tip can no longer be properly controlled (sticking etc.) via the deflection lever, or if the deflection mechanism develops any other fault, the flexible videoscope must not be used.Note: do not squeeze the distal tip of the fiexible videoscope too tightly.Warning: risk of injury: whenever the flexible videoscope is used, you must first check that it, and any accessories used in combination with it, are in perfect condition.Damaged flexible videoscopes or damaged accessories must not be used.Warning: risk of injury: if the image fails or there is interference during use in the patient, put the distal tip into the neutral position and remove the device from the patient's body gently and carefully.If the flexible videoscope continues to be used in the patient after the image has failed or when there is interference, this may result in serious injury to the patient.9.4 handling the sheath attention: risk of damage to the sheath: do not carry the flexible cystoscope hd view by the sheath.Do not pull, clamp or twist the sheath of theflexible cystoscope hd view.The sheath of the flexible cystoscope hd view must not be kinked or coiled up too tightly.It is best to store the flexible cystoscope hd view in a suspended position or to keep it sterilized in a tray specifically designed for sterilizing and storage (39403 as).Warning: risk from damage: faulty flexible videoscopes must not be used.Before each use, check the functionality of the deflection lever and the distal tip.Attention: the distal tip of the flexibleendoscope must be in the neutral position during storage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FLEXIBLE VIDEO CYSTO HD-VIEW, SCOPE ONLY
• Common Device Name: FLEXIBLE VIDEO CYSTO HD-VIEW, SCOPE ONLY
• 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: 21998244
• Report Number: 1221826-2025-00828
• Device Sequence Number: 9484882
• Product Code: FAJ
• UDI-Device Identifier: 04048551423226
• UDI-Public: 04048551423226
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K191357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 11272VH
• Device Catalogue Number: 11272VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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