MAUDE Adverse Event Report: VYAIRE MEDICAL INC. GREENLIGHT¿ SINGLE PATIENT USE ISO GREEN STANDARD STAINLESS STEEL LARYNGOSCOPE B; LARYNGOSCOPE, RIGID

Model Number	BLADE, LARYN, STEEL, GREEN STD, MAC 3
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical that before and during attempts to intubate the patient, the blade, laryn, steel, green std, mac 3 would slide out and snap off the handle when it was raised to click into the handle and turn on the light.The customer confirmed no harm was done to the patient although it required two hands to hold the product together when switching from standby.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: GREENLIGHT¿ SINGLE PATIENT USE ISO GREEN STANDARD STAINLESS STEEL LARYNGOSCOPE B
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15718905
• Report Number: 8030673-2022-00279
• Device Sequence Number: 7233199
• Product Code: CCW
• UDI-Device Identifier: 10190752147584
• UDI-Public: (01)10190752147584
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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: BLADE, LARYN, STEEL, GREEN STD, MAC 3
• Device Catalogue Number: 4603EU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown