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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 320634302
• Report Number: 8030673-2023-00342
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10190752147591
• UDI-Public: (01)10190752147591(10)0004229199
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1