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	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the light of the handle was flickering".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the light of the handle was flickering".No patient involvement reported.
Additional Manufacturer Narrative
Qn#: (b)(4).The customer returned one 133300 rusch greenled handle: medium for investigation.The visual examination did not reveal any obvious defects or anomalies, as the device appears typical.There were deep scratch marks noted on the internal locking mechanism of the handle.These marks reveal that the device has been used multiple times by the end user, and they are indicative of increased wear or groove is worn out.Functional inspection was performed per laryngoscope handle ifu by pushing downward on the blade to release it from the handle.The blade was able to be removed from the handle with ease.The blade and handle were reattached and disassembled multiple times with no issues observed of light flickering as reported in complaint.There were no anomalies revealed during functional testing that would be contributing for light flickering of blades for an end user in any way.The device history record for lot code 191001 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The ifu for this product states, "pre-use checks: before use, always check: the device is free from damage.Battery cartridge is attached securely.Illumination is optimal when a blade is firmly attached.If dim, or if flickering occurs, replace batteries, or replace blade and repeat illumination checks." part of the instructions for use (ifu) inspection and controls states: "under normal conditions, device function and the integrity of materials are not affected by continuous reprocessing.Always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices.After reprocessing, replace the batteries and reassemble battery cartridge.Always perform pre-use checks." the complaint of a light flickering cannot be confirmed.The customer returned the one actual complaint sample of rusch greenled handle and visual examination did not reveal any obvious defects or anomalies as the device appears typical.Functional testing revealed that the handle was working as intended and no issues of light flickering were noted.The product was manufactured in oct 2019.The device history record 191001 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to the release specifications.Based on receipt of the complaint sample and on the functional testing performed on the device it is found that this is not a justified complaint as no problem was found with the returned device.Teleflex will continue to monitor and trend on complaints of this nature.

• 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 ; 9193614124
• MDR Report Key: 14842977
• Report Number: 8030121-2022-00024
• Device Sequence Number: 17303278
• Product Code: CCW
• UDI-Device Identifier: 14026704625656
• UDI-Public: 14026704625656
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/17/2022

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 Model Number: IPN048573
• Device Catalogue Number: 133300
• Device Lot Number: UNKNOWN
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/10/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown