MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED

Model Number 500-000-000-

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Sore Throat (2396)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

Article title: arytenoid cartilage dislocation mimicking bilateral vocal cord paralysis.Published: 11 october 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, the device was used to intubate the patient during a transurethral resection of bladder tumors.The duration of surgery was 25 minutes.In the recovery room, the patient complained of sore throat and dyspnea with inspiratory stridor, which were not resolved after intravenous injection of 10mg of dexamethasone.The otolaryngological examination revealed midline fixation of the bilateral vocal folds, suggestive of bilateral arytenoid dislocation or bilateral vocal cord palsy.Under general anesthesia, a closed reduction was performed using laryngoscopic forceps to apply posterolateral pressure on the arytenoid joints on both sides.Only the dislocation of the left cricoarytenoid joint could be easily reduced, whereas reduction of the right joint was not possible.On postoperative day 7, examination with a rigid laryngoscope showed a medially fixed right vocal fold, with full compensation by the left vocal fold.Six weeks after surgery, the patient had regained normal voice with no complications.

• 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: 8418856
• MDR Text Key: 138760714
• Report Number: 3010244187-2019-00003
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/13/2019

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: 500-000-000-
• Device Catalogue Number: 500-000-000-
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR