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 4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that during intubation of the patient the anesthesiologist noticed different light on blade, laryn, steel, green std, mac 4.After a successful intubation, the blade was inspected and there was a 1 cm piece missing/broken off the tip.It was confirmed that no harm was done to the patient.
Additional Manufacturer Narrative
H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.According to the hospital incident log, the area,bins,the packet and floors were searched for the missing piece and nothing was found.After the procedure, bronchoscopy was done by the anaesthetist and a chest x-ray was performed and no evidence of a foreign body was found.Upon extubation andrecovery the patient had no signs of coughing or airway issues.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h10 result of investigation: based on the investigation and per pictures and decontaminated physical sample received, we confirmed the reported defect since the physical sample was visually inspected according to pqas 4602 etal and it was observed that the fiber part number 070-720004a (used for the manufacture of the fg 4604eu) came broken as seen in the pictures provided for the investigation.Based on this, we determined that manufacturing equipment is related with the reported defect since after the manufacture of the reported lot number 0004229199 there was an improvement on the poka - yoke/ support fixture used on the welding process of the blade manufacturing line.This change on the design improves the process by preventing the fiber from breaking.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 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17446580
• Report Number: 8030673-2023-00342
• Device Sequence Number: 7348147
• Product Code: CCW
• UDI-Device Identifier: 10190752147591
• UDI-Public: (01)10190752147591(10)0004229199
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Model Number: BLADE, LARYN, STEEL, GREEN STD, MAC 4
• Device Catalogue Number: 4604EU
• Device Lot Number: 0004229199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown