MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EQUIPLITE SINGLE USE METAL BLADE MAC 3; LARYNGOSCOPE, RIGID

Catalog Number 004651003

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: the light on the blade is flickering when connected to the handle.The issue was detected prior to use on a patient, during pre-testing.

• Brand Name: RUSCH EQUIPLITE SINGLE USE METAL BLADE MAC 3
• 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: 10379683
• MDR Text Key: 202090709
• Report Number: 8030121-2020-00116
• 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: Other
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004651003
• Device Lot Number: 1910731
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2019
• 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
• Treatment: LARYNGOSCOPE HANDLE