MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE SET

Catalog Number 0055501

Device Problems Failure to Conduct (1114); Optical Problem (3001)

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

Event Date 04/09/2015

Event Type  malfunction  

Event Description

The customer alleges that when the light source is pressed down to activate; the light flickers.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).At visual inspection the handle did not reflect any signs of abuse, neglect, or misuse.A standard, reusable fiber optic blade was attached to the truled handle and engaged.At engagement the led light source did flicker.On this device, the led light is part of an electro-mechanical cartridge that houses the led light source itself and the rechargeable battery pack.When the led light source is depressed by an engaging blade it makes contact with a small pcb (printed circuit board) which draws energy from the battery and manages the led.The defect will either be associated with the pcb, or the electro-mechanical contact point in the self-contained cartridge.The complaint has been confirmed.The defect is related to a faulty pcb or failing electro-mechanical contact.No corrective/preventative actions will be assigned.

• Brand Name: RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE SET
• 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, NC 27560 ; 919434965
• MDR Report Key: 4749243
• MDR Text Key: 5825033
• Report Number: 1044475-2015-00156
• 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: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0055501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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