MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREN RUSCHLITE DISP MTL MAC 4; LARYNGOSCOPE BLADE

Catalog Number 004551004

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

The customer alleges that the blade failed to light on the handle.The alleged issue was detected during pre-testing.No patient injury.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

• Brand Name: RUSCH GREN RUSCHLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE BLADE
• 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, ND 27560 ; 9194334965
• MDR Report Key: 4315348
• MDR Text Key: 20455773
• Report Number: 1044475-2014-00345
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2014

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: Other
• Device Catalogue Number: 004551004
• Device Lot Number: 1401342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/12/2014
• 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
• Treatment: LARYNGOSCOPE HANDLE