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

Model Number 11301BNX

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE, REUSABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 16513707
• MDR Text Key: 311042022
• Report Number: 2020550-2023-00053
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551314609
• UDI-Public: 4048551314609
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2023,03/09/2023

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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1