MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 2; LARYNGOSCOPE, RIGID

Model Number IPN923882

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "blades in the new design are movable.They don't fit properly on the handle".The report states that "the event took place during the procedure.While feeding the laryngoscope, the spoon fell to the ground.The patient was not injured.No additional intervention was necessary.Another laryngoscope blade was used to intubate the patient".The patient status is reported as "fine".

Event Description

Reported as "blades in the new design are movable.They don't fit properly on the handle".The report states that "the event took place during the procedure.While feeding the laryngoscope, the spoon fell to the ground.The patient was not injured.No additional intervention was necessary.Another laryngoscope blade was used to intubate the patient".The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was available to be returned for analysis.A device history record review was performed, and no relevant findings were identified.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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 2
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17606717
• MDR Text Key: 321775360
• Report Number: 8030121-2023-00020
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704663115
• UDI-Public: 14026704663115
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: Health Professional
• Device Model Number: IPN923882
• Device Catalogue Number: 004551002
• Device Lot Number: 230408321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2023
• 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