MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. VIDEO LARYNGOSCOPE; LARYNGOSCOPE, NON-RIGID

Model Number 11303BNX

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2023

Event Type  malfunction  

Event Description

During bronchoscopy, camera malfunctioned making it unable to visualize field.Bronchoscope.

• Brand Name: VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, NON-RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 17080574
• MDR Text Key: 316811399
• Report Number: MW5118246
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2023

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: 11303BNX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male