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 Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).One (b)(4) emerald fo miller blade 2, blade was received for investigation.Upon receipt the blade was visually inspected for any signs of abuse/misuse/damage.Nothing was noted.It should be mentioned that the blade was returned attached to a standard green spec fiber optic handle.The blade was attached to a standard green spec handle, fiber optic, product code 004411100.The report states the handle that was returned is the handle that the blade was stuck on.At inspection the blade was stuck to the handle.The complaint sample blade appears to have been attached to an extremely worn, damaged handle.The handle had deep gashes, pieces of displaced metal, and heavily marred surfaces of the blade retaining ball bearings.It was determined that the blade was sticking due to damaged ball bearings.The complaint has been confirmed, but a lack of detailed circumstances will not allow a definitive root cause assignment.

Event Description

The complaint is reported as: "there new emerald blade attaches to the green spec new handle and will not come off with out extreme force.It also will not disengage after use".No patient injury or harm reported.

• Brand Name: EMERALD FO MILLER BLADE 2
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8655733
• MDR Text Key: 147068219
• Report Number: 8030121-2019-00047
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2019

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: 004452200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1