MAUDE Adverse Event Report: TRI-ANIM HEALTH SERVICES, INC. CURAPLEX CURAVIEW LED FIBER OPTIC LARYNGOSCOPE HANDLE GREEN SYSTEM ITEM:301-FO-M; LARYNGOSCOPE, RIGID

Lot Number 200603A0825

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  Injury  

Event Description

There is a light on the product so clinicians can see where to place intubation.The lights are not coming on, checking the light then it is not working during intubation, and lights being on in the package prior to opening.Fda safety report id# (b)(4).

• Brand Name: CURAPLEX CURAVIEW LED FIBER OPTIC LARYNGOSCOPE HANDLE GREEN SYSTEM ITEM:301-FO-M
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TRI-ANIM HEALTH SERVICES, INC. ; 5000 tuttle crossing blvd. ; dublin OH 43016
• MDR Report Key: 11398444
• MDR Text Key: 234480664
• Report Number: MW5099707
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2021

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 Lot Number: 200603A0825
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR