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
Apologies for the late report, the initial report was submitted on time but the importer was accidently not reported on time.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.

• 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
• MDR Report Key: 20285429
• Report Number: 2020550-2024-00291
• Device Sequence Number: 15307354
• Product Code: FAJ
• UDI-Device Identifier: 04048551423226
• UDI-Public: 04048551423226
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2024
• Report Date (Section F): 08/01/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown