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 Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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
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).

• 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
• MDR Report Key: 20844551
• Report Number: 2020550-2024-00491
• Device Sequence Number: 3838592
• 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): 12/04/2024
• Report Date (Section F): 12/04/2024

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: `0915612-06
• Device Catalogue Number: 0915612-06
• Device Lot Number: 500105782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• 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