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

Model Number	IPN048386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "prior to intubation the hinge and light pipe were dislodged from the blade".Additional information states "per the anesthesia provider the blade split in half and the top part and light part fell off as well".No patient involvement reported.
Event or Problem Description
It was reported "prior to intubation the hinge and light pipe were dislodged from the blade".Additional information states "per the anesthesia provider the blade split in half and the top part and light part fell off as well".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one 004551003 rusch greenlite disposable metal mac 3 for investigation.The blade was returned opened out of its original packaging with a rusch dispoled handle detached.Visual inspection of the returned sample revealed that the blade was broken as it was separated from the metal hinge connector.The light pipe was also found broken at the proximal end where it enters the metal connector.The device history record of lot 1902331 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.According to the manufacturing site, the observed defect is a known issue which is caused by an inadequate welding of the metal joints that hold the blade in place.Corrective actions were implemented in sep 2020 to address the weak welding issue.This device was manufactured in feb 2019, which is prior to the corrective actions.

• 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
• MDR Report Key: 14255317
• Report Number: 8030121-2022-00016
• Device Sequence Number: 14770749
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: IPN048386
• Device Catalogue Number: 004551003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown