MAUDE Adverse Event Report: TELEFLEX MEDICAL GREEN RUSCHLITE DISP MTL MILL 2; LARYNGOSCOPE BLADE

Catalog Number 004550002

Device Problems Connection Problem (2900); Light Interference (2972)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

The customer alleges the blade will not come on once it is engaged with the handle.There was no patient harm reported.Note: defect detected during intubation.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

• Brand Name: GREEN RUSCHLITE DISP MTL MILL 2
• Type of Device: LARYNGOSCOPE BLADE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 4552848
• MDR Text Key: 5460076
• Report Number: 1044475-2015-00108
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 004550002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1