MAUDE Adverse Event Report: FLEXICARE BRITEPRO SOLO

Device Problems Device Inoperable (1663); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Information (3190)

Event Date 12/21/2015

Event Type  Injury  

Event Description

During routine induction of anesthesia, the britepro solo laryngoscope failed during laryngoscopy, despite pre-use check out and confirmation of function prior to use.The miller 2 disposable blade failed with normal pressure applied during the procedure.Video made of device function.Event reappeared after reintroduction, yes.

• Brand Name: BRITEPRO SOLO
• Type of Device: BRITEPRO SOLO
• Manufacturer (Section D): FLEXICARE
• MDR Report Key: 5327159
• MDR Text Key: 34418883
• Report Number: MW5058720
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 97