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

Model Number	IPN048387
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).Other remarks: n/a; corrected data: n/a.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8030121-2023-00013
• Device Sequence Number: 13878190
• Product Code: CCW
• UDI-Device Identifier: 14026737626088
• UDI-Public: 14026737626088
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown