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
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).
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
Result of investigation: as the device has not been sent back for investigation, a final determination of the root cause is not possible.Similar complaints on different single use endoscopes had a variety of root causes for the malfunction, such as: broken articulation.Ruptured steering wires - both caused by excessive force.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22373479
• Report Number: 9610617-2025-01126
• Device Sequence Number: 12818636
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 04048551422519
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: EXEMPT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 091361-06
• Device Catalogue Number: 091361-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown