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

Model Number IPN048387

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Other remarks: n/a; corrected data: n/a.

Event Description

It was reported that "the nurse [reported] that she had little visibility during intubation and then she realized that the laryngoscope blade was broken.The fiber optic light is separated from the blade." multiple attempts were made to inquire whether any plastic parts entered the patient and it they were removed, the current condition of the patient, if there was any patient harm during or after the procedure, if any medical intervention was performed, and how the incident was resolved.The customer did not return any of our inquiries.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "visual examination reveals that the fiber optic (light guide) was cracked and detached from the blade." "the device history record for lot code 230119341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification." the complaint has been confirmed.The manufacturing site reports "the root cause of this complaint is deemed related to packaging because there is no clarity on the pre-testing of the device.There is no clarity on whether a device was tested or not prior to use.Based on the actual complaint device investigation it seems that if the device would have done tested prior to use then this defect could be identified during pre-testing." corrective action has been taken.Other remarks: n/a corrected data: n/a.

Event Description

It was reported that "the nurse [reported] that she had little visibility during intubation and then she realized that the laryngoscope blade was broken.The fiber optic light is separated from the blade.".Multiple attempts were made to inquire whether any plastic parts entered the patient and it they were removed, the current condition of the patient, if there was any patient harm during or after the procedure, if any medical intervention was performed, and how the incident was resolved.The customer did not return any of our inquiries.If additional information is received, the complaint file will be updated.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16712945
• MDR Text Key: 313039696
• Report Number: 8030121-2023-00013
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026737626088
• UDI-Public: 14026737626088
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 230119341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1