MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO MAC 4; LARYNGOSCOPE, RIGID

Model Number 040-334U

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2021

Event Type  Injury  

Event Description

Crna attempt dl with mac 4 britepro solo disposable laryngoscope.Upon attempt blade broke.Blade was removed by crna.A second laryngoscope was then used to intubate the patient without incident.Visual inspection this crna during second intubation did not show obvious harm to patient.After initiating surgery closer inspection of the faulty laryngoscope by this crna showed a missing piece of the broken laryngoscope handle.Attending anesthesiologist and chief anesthesiologist both notified, during which time another crna located all missing pieces of the laryngoscope.Surgery was completed, patient extubated without incident and no complaints or obvious harm noted in pacu.Fda safety report id# (b)(4).

• Brand Name: BRITEPRO SOLO MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD
• MDR Report Key: 11385154
• MDR Text Key: 234218381
• Report Number: MW5099663
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 05055788724124
• UDI-Public: (01)05055788724124
• 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: 02/24/2021

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: 040-334U
• Device Lot Number: 200501631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR