MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Model Number IPN923883

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use on a patient, "the laryngoscope blades are not holding on handles.They don't lock with heine handles, they lock properly with teleflex handles.In our hospital we mainly have heine handles." no patient harm, desaturation, or injury.The patient status is reported as "fine".The issue was resolved by changing the blade.

Event Description

It was reported that during use on a patient, "the laryngoscope blades are not holding on handles.They don't lock with heine handles, they lock properly with teleflex handles.In our hospital we mainly have heine handles." no patient harm, desaturation, or injury.The patient status is reported as "fine".The issue was resolved by changing the blade.

Manufacturer Narrative

(b)(4).The complaint sample was returned.The manufacturing site, truphatek, reported: "the customer returned two blades, one is rusch greenlite disp mtl mac 4 for complaint (b)(4) and another one is for rusch greenlite disp mtl mac 3 for complaint (b)(4).The complaint blades were returned with their original pouch and the complaint cannot be confirmed.The visual examination did not reveal any obvious defects or anomalies, as the devices appear typical.Based on the visual inspection/ dimensional inspection /functional testing performed on the returned blades, it was observed that these complaints cannot be confirmed as there is no problem found on the complaint blades during functional testing and based on the dimensional inspection results, it was noted that the critical dimension 13.80 0.2 mm (total width of blade base) meets the manufacturing and design/drawing release specification for all three blades.The blades were found fully functional, and the blades were locking perfectly with fresh handles.A device history record review was performed, and no relevant findings were identified.The device was manufactured according to the release specification.The devices were tested for 100% functional testing prior to shipment to the customer.The root cause deemed to be "undetermined /unknown" because there is no problem found on the customer retuned complaint devices when tested with fresh handles." 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 3
• 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: 17637442
• MDR Text Key: 322112729
• Report Number: 8030121-2023-00018
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704663122
• UDI-Public: 14026704663122
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN923883
• Device Catalogue Number: 004551003
• Device Lot Number: 230325331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2023
• 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