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

Catalog Number 004432200

Device Problem Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "blade getting stuck on handle".The issue was detected prior to use on a patient.No patient injury or consequence reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.Similar complaints have been received for this issue and a scar has been opened against the supplier (hilbro) for changing ball bearing material.

Event Description

The complaint is reported as: "blade getting stuck on handle".The issue was detected prior to use on a patient.No patient injury or consequence reported.

• Brand Name: EMERALD FO MACINTOSH BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8736158
• MDR Text Key: 149368823
• Report Number: 3011137372-2019-00218
• 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: 06/03/2019

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: 004432200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARYNGOSCOPE HANDLE; LARYNGOSCOPE HANDLE