MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH; LARYNGOSCOPE, RIGID

Model Number IPN048388

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

Anesthesiologist ready to intubate the patient, inserted the laryngoscope blade into the patients mouth.As he looked he quickly removed the blade from the mouth, then used his fingers to retrieve a small 1 1/2 inch piece of tubing.Tubing is green in color and appears to have broken off of the single-use laryngoscope blade.When compared to another laryngoscope, the piece is part of the fiber optic light system that runs along the blade.

• Brand Name: RUSCH
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 8703731
• MDR Text Key: 148207599
• Report Number: 8703731
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019,06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048388
• Device Catalogue Number: 004551035
• Device Lot Number: 1809351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA