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 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during intubation, "the blade did not hold on the rush handle (short), no reference available on the handle".The issue was resolved by using another blade.No patient harm, desaturation, or injury.The patient status is reported as "fine".

Event Description

It was reported that during intubation, "the blade did not hold on the rush handle (short), no reference available on the handle".The issue was resolved by using another blade.No patient harm, desaturation, or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The complaint sample was returned.The manufacturing site, truphatek, reported: "the customer returned two actual 004551003 rusch greenlite disp mtl mac 3 blade (new design launched blade) for investigation.The blades were returned with its original pouch.The visual examination did not reveal any obvious defects or anomalies, as the complaint blades device appears typical.Based on the dimensional inspection results, it was noted that the critical dimension 13.8 0.2 mm (total width of base of blade locking mechanism) meets the manufacturing and design/drawing release specification.The customer returned blades were reattached and disassembled multiple times with fresh handles of rusch greenled medium, and it was noted that the blade was locking on the fresh handles perfectly.There is no problem with blades for locking failure with fresh handle.The returned compliant blades are found to be fully functional when tested with fresh handles.The device history record for lot code 230325331 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The devices were tested for 100% functional testing prior to ship to customer.Based on the dimensional inspection and functional inspection of the returned blades, it was noticed that the complaint device meets the drawing /design specification.There was no problem found on the complaint devices.Functional testing /inspection revealed that the devices are working perfectly when tested with fresh handles." teleflex will continue to monitor and trend on complaints 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: 17736122
• MDR Text Key: 323287573
• Report Number: 8030121-2023-00024
• 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: 08/28/2023

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: IPN923883
• Device Catalogue Number: 004551003
• Device Lot Number: 230325331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/24/2023
• 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