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

Model Number IPN915460

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that while in use, the plastic part of the blade broke into 3 pieces and fell into the patient's throat.All pieces were removed.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that while in use, the plastic part of the blade broke into 3 pieces and fell into the patient's throat.All pieces were removed.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The complaint sample was not returned.The manufacturing site, truphatek, reported: "the complaint for rusch greenlite disp mtl mac 4 products cannot be confirmed as there is no actual complaint device returned at site for physical investigation and without physical complaint device actual root cause could not be determined.A device history record for lot 230119341 was reviewed and no issue that could have contributed to the reported failure was noted.The devices were manufactured according to the release specifications.Dhr record result shows the device was tested 100% for functional testing prior to ship to customer.The root cause of this complaint is deemed to be "undetermined /unknown" because there is no actual complaint device returned for physical investigation.In the event if complaint device will be made available for physical investigation, then this complaint file will be re-opened to document the actual findings based on the physical investigation." teleflex will continue to monitor and trend on complaints of this nature.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17730553
• MDR Text Key: 323201684
• Report Number: 8030121-2023-00021
• Device Sequence Number: 1
• Product Code: CCW
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• 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: 230119341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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