MAUDE Adverse Event Report: INTUBRITE, LLC DISPOSABLE LARYNGOSCOPE BLADE; LARYNGOSCOPE, RIGID

Model Number 1031

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2016

Event Type  malfunction  

Event Description

When the handle and blade were put together it functioned correctly but as it was inserted into the mouth the light began to flicker.A new handle and blade had to be obtained.

• Brand Name: DISPOSABLE LARYNGOSCOPE BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): INTUBRITE, LLC; 2322 la mirada drive; vista, CA 92081
• MDR Report Key: 5909902
• MDR Text Key: 53334097
• Report Number: 5909902
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1031
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1