MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIVE S 3.5X65, STERILE, FOR SINGLE USE,

Model Number	091361-06
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure while intubating the patient using the five s, they deflected the scope and couldn't put it back in the right position.No negative impact in state of health reported.Further information has been received on june 24, 2025.The following was reported: during the procedure, after successful entry into the trachea with the bronchoscope and advancing the endotracheal tube over it, we attempted to withdraw the bronchoscope from the ett (endotracheal tube).Unfortunately, we were unable to do so.Despite multiple attempts and manipulation of the control lever in both upward, downward, and neutral positions, the bronchoscope remained locked in a fixed curved configuration.This created a highly challenging situation.After several forceful attempts, we were eventually able to remove the entire unit, bronchoscope and ett together without causing harm to the patient.However, this necessitated the extubation of a difficult airway, and we had to reintubate the patient using an alternative approach.No negative impact in state of health reported.However, due to the reported unplanned reintubation, this case is deemed reportable.
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 3.5X65, STERILE, FOR SINGLE USE,
• Common Device Name: FIVE S 3.5X65, STERILE, FOR SINGLE USE,
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22373477
• Report Number: 2020550-2025-01126
• Device Sequence Number: 8226494
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 04048551422519
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 07/01/2025
• Report Date (Section F): 07/01/2025

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: 091361-06
• Device Catalogue Number: 091361-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• 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
• Patient Sex: Unknown