MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED ADULT LARYNGOSCOPE HANDLE SET

Catalog Number 0055501

Device Problem Optical Problem (3001)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that the device failed to light during pre-testing.No report of patient injury or harm.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the device failed to light during pre-testing.No report of patient injury or harm.

• Brand Name: RUSCH TRULED ADULT LARYNGOSCOPE HANDLE SET
• Type of Device: LARYNGOSCOPE HANDLE SET
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5232304
• MDR Text Key: 31457900
• Report Number: 1044475-2015-00391
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0055501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1