MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Catalog Number 004551003

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested from the customer.The device has not been returned to the manufacturer.The investigation into this complaint is still in progress.

Event Description

Customer complaint received via med watch ((b)(4)) alleges: "mac 3 blade found in cart broken in packaging.Plastic parts on elbow end broken off." event was reported as detected in the clinical setting.There was no report of patient involvement.

Manufacturer Narrative

(b)(4).Medwatch# (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

Customer complaint received via med watch (0504960000-2017-8008) alleges: "mac 3 blade found in cart broken in packaging.Plastic parts on elbow end broken off." event was reported as detected in the clinical setting.There was no report of patient involvement.

• Brand Name: RUSCH GREEN RUSCHLITE DISP MTL 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: 6661187
• MDR Text Key: 78184473
• Report Number: 8030121-2017-00090
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004551003
• Device Lot Number: 1607332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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