MAUDE Adverse Event Report: TELEFLEX RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE KIT

Catalog Number 005852300

Device Problems Failure to Conduct (1114); Inadequate Lighting (2957)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the blades do not illuminate at all times and some do not function at all.The alleged issues was detected during testing of the device.The customer reports that they disposed of two batteries that were not functioning.

Manufacturer Narrative

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

• Brand Name: RUSCH MRI COND FIBER OPTIC LARYN KIT
• Type of Device: LARYNGOSCOPE KIT
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; po box 12600; research triangle park, NC 27709 ; 9194334965
• MDR Report Key: 3929932
• MDR Text Key: 4604718
• Report Number: 1044475-2014-00068
• Device Sequence Number: 1
• Product Code: OGH
• 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: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 005852300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• 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