MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE, RIGID

Catalog Number 005852300

Device Problems Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Laryngoscope kit was visually inspected for any signs of misuse/abuse/damage.Nothing visually noted.A functional inspection was performed on the blades where both the miller 2 and 3 blades were attached to the mri handle which was returned with the set.Independently, both blades were engaged on the handle and both miller 2 and 3 blades displayed steady, bright beams of light.The complaint cannot be confirmed.Functional testing has determined no fault found with devices in question.The root cause cannot be established.It should be mentioned that the pipe lights were designed in a manner that would allow for easy removal from the blade in order to change out the bulbs should they burn out.The pipe light on the miller 2 was partially dislodged (misaligned) upon receipt.However, this slight misalignment does not represent damage or a defect.The pipe light can be completely removed and reinstalled for bulb or blade maintenance.

Event Description

It was reported that the product was being shown to customer as a sample.The gold color light pipe on the blade becomes dislodged, thus the blade does not fit on the handle properly causing a flickering of the light.No patient involvement.

• Brand Name: RUSCH MRI COND FIBER OPTIC LARYN KIT
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8808289
• MDR Text Key: 151626583
• Report Number: 8030121-2019-00058
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 005852300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2019
• 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
• Treatment: LARYNGOSCOPE HANDLE