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

Device Problem Break (1069)

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

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

H3: 81 other ¿ the customer sent pictures for the investigation.In the pictures, it appears that the fiber is short since it must pass through the blade's cavity.However, it could not be determined if the fiber was broken nor short in the pictures.A physical sample is required to perform a better investigation to determine the fiber conditions.In addition, the device history record was reviewed and there were no issues found during the manufacturing.Therefore, the reported defect was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device was not returned.

Event Description

It was reported to vyaire medical that the fiber tip portion of blade, laryn, steel, green std, mac 3 was broken during patient use.The patient swallowed a portion of the damaged part.Furthermore, there is no information regarding patient harm.

Manufacturer Narrative

Device evaluation:g3,g6,h2,h3,h6 and h10.Result of investigation - the suspect device was returned for product evaluation.Device history record was reviewed no issues were found.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 0004211657 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: 17263927
• MDR Text Key: 318555133
• Report Number: 8030673-2023-00332
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

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
• Device Operator: Health Professional
• Device Model Number: BLADE, LARYN, STEEL, GREEN STD, MAC 3
• Device Catalogue Number: 4603EU
• Device Lot Number: 0004211657
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/28/2023
• 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
• Patient Outcome(s): Other