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

Model Number IPN048386

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

(b)(4).

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 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
• 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: 13476314
• MDR Text Key: 285255198
• Report Number: 8030121-2022-00005
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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 Model Number: IPN048386
• Device Catalogue Number: 004551004
• Device Lot Number: 2105341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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
• Treatment: HANDLE; HANDLE