MAUDE Adverse Event Report: MAGAW MEDICAL COPILOT VL; VIDEO LARYNGOSCOPE

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

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 09/09/2014

Event Type  Injury  

Event Description

After difficult intubation, 3 lacerations were noted to patient's soft palate.The most severe laceration was 3 cm long and 0.5 cm deep and required 3 sutures to close (closed by surgeon).Pt remained in hosp overnight for observation.No further sequelae was noted.

Manufacturer Narrative

Further info regarding the pt injury was unavailable after attempts to reach reporting physician.It is unk if the injury was caused by the disposable sheath, an endotracheal tube, an endotracheal tube introducer, or from multiple attempts at laryngoscopy.According to the initial reporter, there was no evidence of defective or damaged device components.Attempts to contact the reporting physician by phone were made on (b)(6) 2014.

• Brand Name: COPILOT VL
• Type of Device: VIDEO LARYNGOSCOPE
• Manufacturer (Section D): MAGAW MEDICAL; 1120 south fwy; ste 122; fort worth TX 76104
• Manufacturer Contact: jay tydlaska ; 1120 south fwy; ste 122; fort worth, TX 76104 ; 8175331489
• MDR Report Key: 4170308
• MDR Text Key: 5158680
• Report Number: 3008910264-2014-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization