MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID

Model Number 300-000-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Extubate (2402)

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

Title impact of pillow height on double-lumen endotracheal tube intubation with mcgrath mac: a prospective randomized clinical trial source journal of clinical anesthesia, volume 34, 2016 (339¿343) date of publication: 04 may 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, the study aimed to compare the impact of pillow height on double-lumen tracheal tube intubation with mcgrath mac.The authors hypothesized that the use of a high pillow (hp) would allow for more effective double lumen tube intubation with the mcgrath mac compared with a low pillow (lp).None of the patients experienced significant soft tissue injury or desaturation during the trial.The incidence of postoperative pharyngeal pain was significantly different between the hp group (3 patients) and lp group (12 patients) (p =.005).Postoperative hoarseness was observed in 7 patients in the hp group and 10 patients in lp group, which was not significant (p =.37).All intubations were successful.

• Brand Name: MCGRATH
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9132622
• MDR Text Key: 165591710
• Report Number: 3010244187-2019-00009
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 15060272980020
• UDI-Public: 15060272980020
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-000-000
• Device Catalogue Number: 300-000-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other