MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISPOSABLE METAL MAC 3; LARYNGOSCOPE, RIGID

Catalog Number 004551003

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: the blade is broken.The issue was detected prior to use on a patient.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint is reported as: the blade is broken.The issue was detected prior to use on a patient.

• Brand Name: RUSCH GREENLITE DISPOSABLE METAL MAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10637538
• MDR Text Key: 211367376
• Report Number: 8030121-2020-00149
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1702331
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARYNGOSCOPE HANDLE.; LARYNGOSCOPE HANDLE.