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

Catalog Number 004551003

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "blade components fall apart" prior to patient use.

Manufacturer Narrative

Qn#(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturing site reports "it is confirmed that a sample stuck in transit due to covid-19 lockdown announced in india since 24 march 2020 and is available for return.If in the event that the sample is delivered to the investigation site, the complaint will be reopened, and a sample investigation will be conducted.".

Event Description

Customer complaint alleges "blade components fall apart" prior to patient use.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9862648
• MDR Text Key: 189445110
• Report Number: 8030121-2020-00041
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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: 1912331
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1