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

Model Number	IPN048381
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during use for an anesthesia, there was a crack on the blade and the light stopped.".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional 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 or Problem 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
• 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 ; 9193614124
• MDR Report Key: 15614256
• Report Number: 8030121-2022-00028
• Device Sequence Number: 12230736
• Product Code: CCW
• UDI-Device Identifier: 14026704663122
• UDI-Public: 14026704663122
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown