MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS FIBER OPTIC LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID

Model Number VITAL SIGNS® FIBER OPTIC LARYNGOSCOPE HANDLE

Device Problem Break (1069)

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56.If additional information becomes available.

Event Description

The customer reported that the golden part of vital signs® fiber optic laryngoscope handle broke off and fell with the blade on the patient.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation: picture and physical sample reveal that the thread of the handle is broken, confirming the reported failure.Material could be related since this part of the laryngoscope is supplied (manufactured at a different location).It is observed that the thread of the handle is thin, such that during use, it broke easily.(b)(4) was initiated to obtain a further investigation by our supplier.Also incoming inspection personnel and assembly personnel were notified about the complaint.

• Brand Name: VITAL SIGNS FIBER OPTIC LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10960499
• MDR Text Key: 231801003
• Report Number: 8030673-2020-00132
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10190752148055
• UDI-Public: (01)10190752148055
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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: VITAL SIGNS® FIBER OPTIC LARYNGOSCOPE HANDLE
• Device Catalogue Number: 4556EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1