MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH MAC 4 DISPOSABLE LARYNOGOSCOPE BLADE; LARYNGOSCOPE, RIGID

Model Number 350-012-000

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/21/2020

Event Type  Injury  

Event Description

Patient was intubated for a surgical procedure with a mcgrath mac 4 blade.Post procedure in pacu patient appeared congested and coughed a lot.Nurse assessed oral cavity and noticed a plastic foreign body.Nurse removed foreign body and it was discovered to be a mac 4 disposable laryngoscope blade.Once removed, patient condition improved and was discharge for area.Patient's anesthesiologist and surgeon were both made aware of the event.Patient had no additional complaints other than a sore throat in the post op call.Concern for center staff was the blade does not fully secure on the laryngoscope.This increases risk of leaving disposable blade in oral cavity post intubation.Fda safety report id #: (b)(4).

• Brand Name: MCGRATH MAC 4 DISPOSABLE LARYNOGOSCOPE BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED
• MDR Report Key: 10301755
• MDR Text Key: 199914782
• Report Number: MW5095629
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2020

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 Expiration Date: 01/04/2022
• Device Model Number: 350-012-000
• Device Lot Number: P19040102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2020
• 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: 61 YR