MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEX. INTUBATION VIDEO ENDOSCOPE 5.5X65; FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE, REUSABLE

Model Number	11301BNX
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed during use.Upon insertion into the patient's trachea, the image was lost on the c-mac monitor.Upon withdrawal, the image returned.But then the same failure occurred again.Or stuff needs to source an alternative scope to use.This added an extended period to the procedure, apparently turning a procedure that should have lasted approximately thirty minutes into one that lasted an hour and a half.No information about patient harm and the hazard so far.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FLEX. INTUBATION VIDEO ENDOSCOPE 5.5X65
• Common Device Name: FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE, REUSABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 16513707
• Report Number: 2020550-2023-00053
• Device Sequence Number: 20407350
• Product Code: CAL
• UDI-Device Identifier: 04048551314609
• UDI-Public: 4048551314609
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/09/2023
• Report Date (Section F): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11301BNX
• Device Catalogue Number: 11301BNX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown