MAUDE Adverse Event Report: TELEFLEX RUSCH GREENSPEC FO HANDLE MED.; LARYNGOSCOPE HANDLE

Catalog Number 004411100

Device Problems Failure to Conduct (1114); Optical Problem (3001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

The event is repoerted as: the customer alleges that the handle bulb will not energize.

Manufacturer Narrative

Product usage when the alleged defect was encountered is unknown.The device sample was not returned for evaluation at the time of this report.

• Brand Name: RUSCH GREENSPEC FO HANDLE MED.
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; po box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 4094949
• MDR Text Key: 18029404
• Report Number: 1044475-2014-00264
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• 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: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1