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

Model Number IPN923885

Device Problems Disconnection (1171); Optical Obstruction (3002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "male, 30 year-old.During the laryngoscope of a patient during anterior cruciate ligament reconstruction, the fiber optic disconnected from the handle and formed an angle of 45 degrees when pulling out.Additional information: direct view on the glottis was obstructed by the optic fiber.Another device was used and the patient has been since discharged and sent home.

Manufacturer Narrative

(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "the customer has returned one actual 004551004 rusch greenlite disp mtl mac 4 blade (new design launched blade) for investigation.The visual examination did not reveal any obvious defects or anomalies, as the complaint blade device appears typical.The fiber optic was intact properly on the blade.Functional inspection was performed just to confirm the device functionality related to illumination and locking and unlocking onto the handle, but customer reported defect could not be replicated or reproduced during functional testing as the customer reported failure is related to the usability of the device and this defect is possible to confirm only during the actual application of the device on the patient.The manufacturing site has confirmed the device per design /drawing specifications and found that the device meets the design drawings specifications.The device history record for lot code 230503341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The devices were tested for 100% functional t esting prior to ship to customer.Based on the visual inspection and functional inspection performed on the customer's returned blade, it was noticed that the complaint device is found fully functional, but customer reported defect could not be replicated or reproduced during functional testing as the customer reported failure is related to the usability of the device and this defect is possible to confirm only during the actual application of the device on the patient.Therefore, the root cause for the reported complaint is deemed undetermined /unknown.This complaint cannot be confirmed.No problem found on the complaint device." teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "male, 30 year-old.During the laryngoscope of a patient during anterior cruciate ligament reconstruction, the fiber optic disconnected from the handle and formed an angle of 45 degrees when pulling out.Additional information: direct view on the glottis was obstructed by the optic fiber.Another device was used and the patient has been since discharged and sent home.

• 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: 18449834
• MDR Text Key: 332728216
• Report Number: 8030121-2024-00003
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN923885
• Device Catalogue Number: 004551004
• Device Lot Number: 230503341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 110 KG