MAUDE Adverse Event Report: TELEFLEX MEDICAL EMERALD FO MILLER BLADE 2; LARYNGOSCOPE, RIGID

Catalog Number 004452200

Device Problem Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "blades appear that they are too tight on the handle causing them to jam and not release from handle." during pre-testing.There was no patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Complaint description states the blade is too tight, or "jammed" onto the laryngoscope handle.The blade in question was received unattached to a handle.The blade was attached to a test lab standard fiber optic metal reusable laryngoscope handle (product code 004411100).Once attached the blade was engaged, and disengaged multiple times without any unusual resistance or unusual force required to disengage it.Based on the investigation performed, the reported complaint could not be confirmed.There were no issued found with the returned device.

Event Description

Customer reported "blades appear that they are too tight on the handle causing them to jam and not release from handle." during pre-testing.There was no patient involvement reported.

• Brand Name: EMERALD FO MILLER BLADE 2
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8981448
• MDR Text Key: 166757516
• Report Number: 3011137372-2019-00295
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004452200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.