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

Model Number	REF 004551003 (IPN048386)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 8772775
• Report Number: MW5087963
• Device Sequence Number: 19305349
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: (01)14026734626074
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: REF 004551003 (IPN048386)
• Device Lot Number: 1811331
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Weight: 86