MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Model Number IPN048381

Device Problem Material Fragmentation (1261)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that: "during use for an anesthesia, there was a crack on the blade and the light stopped.".

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

Qn#(b)(4).The sample was returned to the manufacturing site for evaluation.The manufacturing site reports: "the customer returned one 004551003 rusch greenlite disp mtl mac 3 blade for investigation.The blade was returned without its original pouch.Visual examination reveals that the fragment of plastic (light guide) was cracked and detached from the blade." it was also reported that functional testing could not be performed as the light pipe was broken on the blade and could not be used for functional testing.The device history record for lot# of the sample received (2j0122) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturer's conclusion: "the root cause of this complaint is deemed related to packaging because the customer confirmed that during pre-testing of the blade, the device was working fine and illumination was sufficient, but when the blade was used during the procedure there was a crack on the blade and the light stopped.The blade was then removed, and the doctor observed a fragment of plastic detached from the blade.This could only be possible if the light pipe will have a minor crack developed inside the packaging due to external impact during transportation, and this minor crack might have contributed to light guide breakage when the customer mounted the blade on the handle.Therefore, it seems that for some reason, it sustained unexplained physical damage." a capa has been opened to further investigate this issue.Corrected data: section d.1.-corrected to rusch greenlite disp mtl mac 3 section d.4.-cat no.Corrected to 004551003.Section d.4.-udi# corrected to (b)(4).

Event Description

It was reported that: "during use for an anaesthesia, there was an incident: there was a crack on the blade and the light stopped.The blade was removed and we observed a fragment of plastic detached from the blade.There was no consequence for the patient.Another blade was used with success to intubate the patient." additional information received from the customer indicates there was no patient desaturation during the change of blade and the plastic piece was recovered.There was no report of patient injury/harm.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 3
• 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 ; 9193614124
• MDR Report Key: 15614256
• MDR Text Key: 306914350
• Report Number: 8030121-2022-00028
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704663122
• UDI-Public: 14026704663122
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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 Operator: Health Professional
• Device Model Number: IPN048381
• Device Catalogue Number: 004551003
• Device Lot Number: 514003A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1