MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Model Number	IPN048386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the anaesthetist tried to connect the blade to the handle, but he faced difficulty and the plastic part of the blade broke at the connection level.There was a delay in the process of the intubation because the staff needed get a spare device.The staff grabbed and used another device working properly.The patient deceased but there is no link with the incident.He died from a natural cause.".
Event or Problem Description
It was reported that "the anaesthetist tried to connect the blade to the handle, but he faced difficulty and the plastic part of the blade broke at the connection level.There was a delay in the process of the intubation because the staff needed get a spare device.The staff grabbed and used another device working properly.The patient deceased but there is no link with the incident.He died from a natural cause.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned the actual sample involved in the event in addition to a rusch laryngoscope handle.The samples were forwarded to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the light pipe on the blade was broken, but the spot welding joint was intact.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.The manufacturer also reports: "it has been identified that defective handle is not compatible for greenlite products because greenlite blades have fibre optic light pipe therefore green spec handles are recommended for fibre optic blades.Even in complaint summary note,it is clearly stated that the anesthetist tried to connect the blade to the handle but he faced difficulty and found it impossible to connect, he forced to make the connection and the plastic part of the blade broke at the connection and as per investigation outcome it is identified that the head width of the handle complaint sample is less as compare to green spec handle which actually restrict the entry of blade in the head and can cause light pipe breakage of blade.In further investigation to confirm the light guide breakage of products, we took the fresh blades of greenlite family and performed the fitment testing with complaint sample and as well as with green spec handle and we have observed that blades were compatible with green spec handle whereas blades were not compatible with the handle complaint sample and we have faced difficulty and found impossible to connect the blade with handle and we applied force on the blade to make the connection and that time light pipe of the blade got broke." based on the investigation performed, it was identified that the customer has used the wrong handle for application, causing the light pipe to break during engagement onto the handle.The handle that was returned is not compatible for the greenlite products family blade.This is a user related error of wrong product selection for use.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11493803
• Report Number: 8030121-2021-00009
• Device Sequence Number: 14452310
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN048386
• Device Catalogue Number: 004551004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE; HANDLE; HANDLE
• Outcome Attributed to Adverse Event: Death