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

(b)(4).

Event Description

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

Event Description

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

Manufacturer Narrative

(b)(4).The sample was received and forwarded to the supplier (hilbro) for evaluation.The supplier reports "after investigation we come to know that it happened because the stainless steel (aisi 304) balls used in these blades are soft.Although we normally use these balls in laryngoscope blades and it doesn't make any problem with brass handles, as brass is a soft material so it does not damage the balls and it work properly.In your case the handle is made of stainless steel material that is a hard material so after some use it damaged the soft stainless steel balls which make the balls stuck and caused the fitting problem." the supplier also reports "we have produced some samples with hard stainless steel (aisi 316) balls and checked several times on your stainless steel handles but the stainless steel balls did not damage and work properly.We have communicated the production workers to use hard stainless steel (aisi 316) balls for your product range so that this issue does not occur in future.This change has been implemented in the shipment dated 9 august 2019 and will be implemented in all the future shipments." a scar has been opened against hilbro as a corrective/preventative action that will be taken to ensure material changes are managed per teleflex supplier quality procedures.

• Brand Name: EMERALD FO MACINTOSH BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8736107
• MDR Text Key: 149247319
• Report Number: 3011137372-2019-00217
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• 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: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARYNGOSCOPE HANDLE; LARYNGOSCOPE HANDLE; LARYNGOSCOPE HANDLE