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

Model Number	040-334U
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD
• MDR Report Key: 11385154
• Report Number: MW5099663
• Device Sequence Number: 3256695
• Product Code: CCW
• UDI-Device Identifier: 05055788724124
• UDI-Public: (01)05055788724124
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: 040-334U
• Device Lot Number: 200501631
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR