MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENSPEC FO HANDLE MEDIUM; LARYNGOSCOPE HANDLE

Catalog Number 004411100

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/30/2014

Event Type  malfunction  

Event Description

The customer alleges that the handles are not functioning properly.The blade sticks on the handle and is difficult to mount.No pt injury.

Manufacturer Narrative

The device sample was not returned by eval at the time of this report.

• Brand Name: RUSCH GREENSPEC FO HANDLE MEDIUM
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4488343
• MDR Text Key: 5497428
• Report Number: 1044475-2015-00023
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004411100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1