MAUDE Adverse Event Report: TELEFLEX RUSCH GREENSPEC STUBBY HANDLE; LARYNGOSCOPE HANDLE

Catalog Number 004413300

Device Problems Mechanical Problem (1384); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the handle is not re-connecting leaving the base and cap separate from the body of the handle.The customer alleges that the issue occurred during an intubation.Another blade and handle set was obtained.No report of a pt injury.

Manufacturer Narrative

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

• Brand Name: RUSCH GREENSPEC STUBBY HANDLE
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; po box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3837908
• MDR Text Key: 4621701
• Report Number: 1044475-2014-00057
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/11/2014

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: 004413300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1