MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLED HANDLE: MEDIUM; LARYNGOSCOPE, RIGID

Model Number	IPN048573
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "several anaesthetists experienced "false contact" issues when using laryngoscopes with a blinking light during intu bation".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned, and sent to the manufacturing site for investigation.The manufacturing site reports that a visual exam was performed.And it was observed, that the bottom cap of the device was loose and not tightened properly.Functional testing was performed.And the bottom cap was tightened properly and the blade was attached to the handle.The light from the blade was constant and glowing perfectly.A device history record for lot code 200701 was reviewed.And no issues were that could have contributed to the reported failure.The device was manufactured according to release specification.Based on the investigation performed.It was identified, that bottom cap of the complaint handle was found loose and not tightened properly, which cause the light flickering issues of handle and blade.So it is concluded, that this is a user related error.
Event or Problem Description
It was reported, "several anaesthetists experienced "false contact" issues.When using laryngoscopes with a blinking light, during intubation".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: RUSCH GREENLED HANDLE: MEDIUM
• 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: 12807723
• Report Number: 8030121-2021-00038
• Device Sequence Number: 4757532
• Product Code: CCW
• UDI-Device Identifier: 14026704625656
• UDI-Public: 14026704625656
• 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): 10/25/2021

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: IPN048573
• Device Catalogue Number: 133300
• Device Lot Number: 200701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown