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

Catalog Number 004551004

Device Problems Use of Device Problem (1670); Optical Problem (3001)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient involved in motor vehicle accident.When ems arrived, the patient was conscious, able to answer questions, and move all four extremities.Ems dediced to delay intubation until the emergency helicopter arrived.The patient was placed under anesthesia prior to intubation.Patient was hospitalized with "a guarded prognosis related to the aftermath of the shock".

Event Description

The customer reported "the laryngoscope blade was snapped on the handle but there was no light.The paramedic removed the blade, pressed the light with his finger and the light was perfectly working.".It was suggested to the doctor to wait to intubate the patient while another device was retrieved from the ambulance, but the doctor declined and attempted intubation with the device without the light.Intubation was unsuccessful and the patient received manual ventilation for 5 minutes before a second attempt was made.During manual ventilation, a new device was retrieved from the ambulance and the patient was successfully intubated on the second attempt.There was no report of respiratory distress or issues prior to the intubation.It was reported that transportation of patient was delayed due to second intubation.At the time of this report the patient was hospitalized in intensive care.

Event Description

The customer reported "the laryngoscope blade was snapped on the handle but there was no light.The paramedic removed the blade, pressed the light with his finger and the light was perfectly working.".It was suggested to the doctor to wait to intubate the patient while another device was retrieved from the ambulance, but the doctor declined and attempted intubation with the device without the light.Intubation was unsuccessful and the patient received manual ventilation for 5 minutes before a second attempt was made.During manual ventilation, a new device was retrieved from the ambulance and the patient was successfully intubated on the second attempt.There was no report of respiratory distress or issues prior to the intubation.It was reported that transportation of patient was delayed due to second intubation.At the time of this report the patient was hospitalized in intensive care.

Manufacturer Narrative

(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports the complaint sample was received brokedn; however, it was tested on a rusch greenled handle and green spex handle, and it was found there was perfect transmission of light from light guide source on blade.The blade was put on engaged position for 10 minutes and no flickering or light disruption was observed.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.The device was received broken; however, no issues were found.The greenlite blade doesn't have an integrated light source, it has transparent fiber optics of pmma which transmits light from led of the handle to the object.If any part of the handle is loose, it might create problems during light transmission.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9129712
• MDR Text Key: 189452596
• Report Number: 8030121-2019-00080
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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
• Device Operator: No Information
• Device Catalogue Number: 004551004
• Device Lot Number: 1903341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANESTHESIA PRIOR TO INTUBATION.; ANESTHESIA PRIOR TO INTUBATION.