MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH; DISPOSABLE LARYNGOSCOPE

Model Number 004550001

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2018

Event Type  Injury  

Event Description

During intubation, the end of the fiberoptic light source of the laryngoscope blade broke off and was lodged in the pt's airway and had to be removed prior to a second attempt to intubate could be preformed.

• Brand Name: RUSCH
• Type of Device: DISPOSABLE LARYNGOSCOPE
• Manufacturer (Section D): TELEFLEX MEDICAL ; triangle park NC 27709
• MDR Report Key: 8084817
• MDR Text Key: 128029278
• Report Number: MW5081436
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2018

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: 004550001
• Device Catalogue Number: 431R
• Device Lot Number: 1501412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2018
• 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): Hospitalization
• Patient Age: 15 YR