MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIVE S 5.3X65, STERILE, FOR SINGLE USE

Model Number	0915612-06
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient aspirates and her pulmonary condition deteriorate.Given the overall situation, intubation should be avoided if possible; therefore, the decision is made to perform bronchoscopy under sedation via the nasal route.The endoscope becomes blocked several times due to very thick secretions and must be flushed repeatedly outside the patient.After approximately the third time, the cold light illumination at the front of the bronchoscope fails.The image from the camera is still visible on the monitor under room lighting, but as soon as the scope is inserted into the nostril, visibility is lost because there is no light.The bronchoscopy must be discontinued.The patient was reintubated following further pulmonary deterioration; however, this would likely have been necessary even if the bronchoscopy had been successful.Due to discontinuation of bronchoscopy and reintubation, a report is required.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FIVE S 5.3X65, STERILE, FOR SINGLE USE
• Common Device Name: FIVE S 5.3X65, STERILE, FOR SINGLE USE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24779697
• Report Number: 2020550-2026-00736
• Device Sequence Number: 18625763
• Product Code: EOQ
• UDI-Device Identifier: 04048551446690
• UDI-Public: 04048551446690
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/02/2026
• Report Date (Section F): 04/02/2026

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: 0915612-06
• Device Catalogue Number: 0915612-06
• Device Lot Number: 500101553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown