MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW

Model Number	11272VH
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that the examination failed completion of the medical procedure due to faulty non clear vision from the camera lens was reported.No harm to patient, user or third reported.There is no information whether the surgery needed to be postponed or changed, a different device was used, and which medical intervention was necessary.Therefore, as a precaution, the case is deemed reportable.
Additional Manufacturer Narrative
The product was returned on 2024-08-01 and the investigation was completed on 2024-09-11.A visual inspection and a functionality test of the device was performed and the error described by the customer could not be confirmed.The endoscope is in good condition only minor scratches were found due to user error and wear and without any impact of the functionality.These minor damages are not the cause of the image failure.No distal lens damage, the image is in good condition, even after 30 minutes burn-in test.Possible root causes for the picture failure can be assumed in the picture chain, e.G.A loose contact of a cable or an incorrectly inserted plug.If a defect in another piece of equipment used in the picture chain, e.G.Tele pack or monitor had occurred, the fault would still occur at the customer's premises and would have been noticed by the customer.The most probable cause which can lead to a picture failure would be image interruption/changes caused by use of hf surgical equipment.However, the ifu states that a functionality check must be carried out before each use and a check for clear view and steerability.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
This report is to correct section h1 to reflect the accurate severity of the event.The last supplemental report was reflected incorrectly as a malfunction instead of a serious injury.Internal karl storz reference number: (b)(4).

• Brand Name: FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW
• Common Device Name: FLEXIBLE VIDEO CYSTOSCOPE
• 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: 19984463
• Report Number: 1221826-2024-00291
• Device Sequence Number: 17942365
• Product Code: FAJ
• UDI-Device Identifier: 04048551423226
• UDI-Public: 04048551423226
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 01/30/2025
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/24/2024; 01/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown