MAUDE Adverse Event Report: RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Model Number IPN915460

Device Problem Break (1069)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported "the anaesthetist [reported] that during tracheal intubation a plastic piece of the device was seen inside the patients mouth.There was no apparent injury caused to the patient.Further investigations conducted to locate the piece.Lungs and oesophagus checked as well as the surrounding area, in case had come out".No patient harm reported.Patient condition reported as "fine".

Event Description

It was reported "the anaesthetist [reported] that during tracheal intubation a plastic piece of the device was seen inside the patients mouth.There was no apparent injury caused to the patient.Further investigations conducted to locate the piece.Lungs and oesophagus checked as well as the surrounding area, in case had come out".No patient harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The actual device was not returned; however the customer provided a photo for evaluation.The photo was reviewed and it was found that the light pipe was broken, thus the complaint was confirmed.The device history record for lot code 2104341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturer reports that corrective action has been taken in december 2019 and includes the following: restrict movement of product inside the inner carton to avoid collision of products with each and possibility of breakage of light guide inside the box.Cover all six walls of the inner box with a bubble sheet to absorb unexplained shock during transportation handling.Purpose of this to absorb shock throughout the supply chain from the manufacturing site to hospitals via distribution center dealers.The manufacturer also reports a "design change of light guide for rusch greenlite products and currently project is under design and development phase and project will be close in (b)(6) 2022.".

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• MDR Report Key: 12440538
• MDR Text Key: 270356587
• Report Number: 8030121-2021-00027
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026737626088
• UDI-Public: 14026737626088
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: IPN915460
• Device Catalogue Number: 004551004
• Device Lot Number: 2104341
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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