MAUDE Adverse Event Report: TELEFLEX RUSCH EQUIPLITE MTL DISP MAC 3; LARYNGOSCOPE BLADE

Catalog Number 004651003

Device Problems Connection Problem (2900); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

The event is reported as: the light flickers on and off during use.The blade does not fit snug on the handle.No patient harm/injury or consequence.

Manufacturer Narrative

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

• Brand Name: RUSCH EQUIPLITE MTL DISP MAC 3
• Type of Device: LARYNGOSCOPE BLADE
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 4208920
• MDR Text Key: 4983818
• Report Number: 1044475-2014-00288
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 004651003
• Device Lot Number: 1401732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• 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