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

Model Number	IPN048386
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the hospital faced two incidents during a situation of emergency intubation procedure.The blade did not snap properly on the handle.The consequence was a lighting fault and a damage of the handle".No patient harm or injury reported.Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(6).The actual device was not returned; however, the customer provided a photo for evaluation.The manufacturing site reports that a visual exam was conducted on the photo and "it has been identified that the groove of the handle seems damaged/worn out and there could be possibilities that due damaged/worn-out groove customer has faced the issue of handle and blade." the device history record for lot code 2105341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The ifu for this product states: "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the hospital faced two incidents during a situation of emergency intubation procedure.The blade did not snap properly on the handle.The consequence was a lighting fault and a damage of the handle".No patient harm or injury reported.Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.

• 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: 13476314
• Report Number: 8030121-2022-00005
• Device Sequence Number: 5387460
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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 Expiration Date: 04/15/2026
• Device Model Number: IPN048386
• Device Catalogue Number: 004551004
• Device Lot Number: 2105341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE; HANDLE
• Patient Sex: Unknown