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

Model Number	`0915612-06
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that when inserting the intubation video endoscope into the tube, streaks in the image display on the c-mac monitor and image dropouts occurred.Procedure was not completed and bronchoscopy delayed, a second bronchoscope had to be organized to finish the broncheoalveolar lavage.
Additional Manufacturer Narrative
Additional information is provided to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
When inserting the intubation video endoscope into the tube, streaks in the image display on the c-mac monitor and image dropouts occurred".Procedure was not completed and bronchoscopy delayed, a second bronchoscope had to be organized to finish the bronchoalveolar lavage.Therefore this case is reportable.
Additional Manufacturer Narrative
Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
New information was provided that no death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The product was found to be fully functional, with no detectable damage.The most likely root cause of the reported issue is that the plug was not properly connected to the monitor.The procedure was completed successfully without any harm to the patient.The doctor/user switched to a different device, allowing the operation to proceed without further issues.Consequently, the reported issue does not meet the criteria for a serious incident and is therefore it is not reportable.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction isn made in section h11 to reflect that this event is not a serious injury.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: FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE
• 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: 20844516
• Report Number: 9610617-2024-00491
• Device Sequence Number: 15517835
• Product Code: EOQ
• UDI-Device Identifier: 04048551446690
• UDI-Public: 04048551446690
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K212656
• 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,Followup,Followup
• Report Date (Section B): 02/28/2025

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: `0915612-06
• Device Catalogue Number: 0915612-06
• Device Lot Number: 500105782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 12/28/2024; 12/27/2024; 01/29/2025; 01/29/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/09/2025; 01/10/2025; 02/28/2025; 02/28/2025
• 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