MAUDE Adverse Event Report: TELEFLEX MEDICAL DISPOLED DISP FO LARYNOGOSCOPE HANDLE; LARYNGOSCOPE HANDLE

Catalog Number 77700

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2014

Event Type  malfunction  

Event Description

The complaint is reported as the led light flickering after the blade was engaged during pretesting.There was no patient involvement during the reported defect.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• Brand Name: DISPOLED DISP FO LARYNOGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; po box 12600; research triangle park, NC 27709 ; 9194334854
• MDR Report Key: 4023742
• MDR Text Key: 4729014
• Report Number: 1044475-2014-00233
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2014

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 Catalogue Number: 77700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/14/2014
• 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