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

Model Number	IPN049940
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
Customer reported that: "the blades are getting stuck on the handle." no patient injury or consequence reported.Patient condition reported as "fine.".
Additional Manufacturer Narrative
(b)(6).Further investigation was performed and the device was sent to the manufacturing site.The site has confirmed that the product is de fective.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 or Problem Description
Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".
Event or Problem Description
Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(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 numbers 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 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.

• Brand Name: RUSCH EMERALD FO MACINTOSH BLADE
• Common Device Name: 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: 14836346
• Report Number: 3011137372-2022-00104
• Device Sequence Number: 4832605
• Product Code: CCW
• UDI-Device Identifier: 14026704640260
• UDI-Public: 14026704640260
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/22/2022; 07/27/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/25/2022; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE.; HANDLE.; HANDLE.
• Patient Sex: Unknown