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

Model Number	VITAL SIGNS® FIBER OPTIC LARYNGOSCOPE HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10960499
• Report Number: 8030673-2020-00132
• Device Sequence Number: 10922962
• Product Code: CCW
• UDI-Device Identifier: 10190752148055
• UDI-Public: (01)10190752148055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1