MAUDE Adverse Event Report: TELEFLEX RUSCH GREENSPEC FO HANDLE SMALL; LARYNGOSCOPE HANDLE (FIBEROPTIC)

Catalog Number 004412200

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges that the blade is stuck on the handle.No report of a pt injury.

Manufacturer Narrative

Pt identifier.It is unk if the device was in use on a pt.The device sample was received by the mfr, but the investigation is incomplete at the time of this report.

• Brand Name: RUSCH GREENSPEC FO HANDLE SMALL
• Type of Device: LARYNGOSCOPE HANDLE (FIBEROPTIC)
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn, reg affairs ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3851587
• MDR Text Key: 16859492
• Report Number: 1044475-2014-00073
• 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: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 004412200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1