MAUDE Adverse Event Report: VYAIRE MEDICAL. 4558GSP- GREENLIGHT FIBER OPTIC LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID

Model Number 4558GSP- GREENLIGHT¿ FIBER OPTIC LARYNGOSCOPE HANDLE

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The vyaire medical conducted a failure investigation and determined that there is no issues were found with the product reported by the customer due to instruction for use in p/n 36-20919 states that the product is exclusive for use with vital signs single-patient-use fiber optic laryngoscope blade, manufactured by vital signs, inc.And the product is not compatible with iso green standard blade.Therefore, no corrective or preventive actions will be applied.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the instruction for use in greenlight¿ fiber optic laryngoscope handle states that this is not compatible with iso green standard blade.However, the customer used the product on a patient which caused a delay in treatment, but the customer advised that there was no patient harm associated with this event.

• Brand Name: 4558GSP- GREENLIGHT FIBER OPTIC LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion85; parque undustrial mexicali iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 9787049
• MDR Text Key: 200616405
• Report Number: 8030673-2020-00088
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 55885403271739
• UDI-Public: (01)55885403271739(11)190805(10)0004107876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2019

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: Health Professional
• Device Model Number: 4558GSP- GREENLIGHT¿ FIBER OPTIC LARYNGOSCOPE HANDLE
• Device Catalogue Number: 4558GSP
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1