MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. C-MAC; LARYNGOSCOPE, RIGID

Catalog Number 10331BXK

Device Problems Leak/Splash (1354); Increase in Pressure (1491); Infusion or Flow Problem (2964)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 03/05/2021

Event Type  Injury  

Event Description

Refer to note in aims-barotrauma - pneumoperitoneum and bilateral pneumothoraxes, subsequent code/cpr for bradycardia, desaturation and hypotension.Neonate never appeared to lose pulses, low hr of 60s and low mean bp 27.Caused by oxygen flow via video stylet and its adapter which as designed send o2 via the ett (endotracheal tube) and then into trachea upon intubation.Despite rapid discontinuation of the oxygen flow within 7 seconds, significant life-threatening barotrauma resulted.Expected a 3.0 cuffed ett to allow enough egress for 4 l/min of flow.Despite this reasonable assessment, egress of flow must have been obstructed due to tighter than expected larynx and subglottis during placement and manipulation to remove stylet causing exponentially rising oxygen pressure and subsequent barotrauma.Of note, ett with cuff pressure of 22cmh2o had a leak with pressure > 30.Suggestion for avoiding similar event in the future: no longer allow oxygen flow via the equipment's adapter as too difficult to tell if acceptable egress would be feasible.

• Brand Name: C-MAC
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 11633734
• MDR Text Key: 244440405
• Report Number: 11633734
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10331BXK
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 22 DA