MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE SINGLE-USE METAL LARYNGOSCOPE BLADE FOR FIBER OPTIC SYSTEM; LARYNGOSCOPE, RIGID

Model Number REF 004551003 (IPN048386)

Device Problems Break (1069); Crack (1135); Material Separation (1562)

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

Event Date 07/03/2019

Event Type  malfunction  

Event Description

During routine laryngoscopy, the blade separates from the wedge, cracking the fiberoptic light channel rendering the device nonfunctional.An add'l blade was opened and used successfully.No damage was done to the pt, but the teeth could easily have been damaged by the breakage.Intubation was delayed.We have also experienced multiple breakage events in the past several weeks of a similar nature with various other lots of this blade.Fda safety report id# (b)(4).

• Brand Name: RUSCH GREENLITE SINGLE-USE METAL LARYNGOSCOPE BLADE FOR FIBER OPTIC SYSTEM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 8772775
• MDR Text Key: 150597145
• Report Number: MW5087963
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: (01)14026734626074
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: REF 004551003 (IPN048386)
• Device Lot Number: 1811331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 36 YR
• Patient Weight: 86