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

Model Number IPN049940

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number was not provided.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

Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".

Event Description

Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one emerald rusch mac 3 blade for evaluation.The blade was returned with a rusch greenspec handle attached.The blade was visually inspected for signs of misuse/abuse/damage.Nothing atypical was noted.A dimensional inspection could not be performed on the base of the blade due to the condition of the returned device.The mac 3 blade was functionally tested with the attached greenspec handle per ifu.The ifu states, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down." the blade was not able to be detached from the handle.The blade could not be removed even with significant force applied.R & d engineering was consulted as part of this investigation.R & d confirmed that the blade was defective as it could not be separated by manual force.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The complaint is confirmed.Functional testing was performed and the blade was not able to be detached from the handle.The blade could not be removed even with significant force applied.R & d engineering was consulted as part of this investigation.R & d confirmed that the blade was defective as it could not be separated by manual force.A dhr review was performed based on the sales history with no relevant findings identified.The sample has been sent to the manufacturing site for further evaluation.Teleflex will continue to monitor and trend on complaints of this nature.

Manufacturer Narrative

(b)(4).Further investigation was performed and the device was sent to the manufacturing site.The site has confirmed that the product is defective.The root cause was identified as manufacturing related.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".

• Brand Name: RUSCH EMERALD FO MACINTOSH BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14836530
• MDR Text Key: 302961673
• Report Number: 3011137372-2022-00112
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704640260
• UDI-Public: 14026704640260
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

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 Model Number: IPN049940
• Device Catalogue Number: 004433300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/22/2022; 07/27/2022
• Supplement Dates FDA Received: 07/25/2022; 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HANDLE.; HANDLE.; HANDLE.