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

Model Number	IPN915486
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Customer called stating that the light would not work when the blade is attached.They have changed the blubs and batteries, no change.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 008621000 rusch standard handle: medium for investigation (lot 210501).The customer also returned one rusch standard mac 3 blade (008603300, lot 74e2202507).Visual examination did not reveal any obvious defects or anomalies.The device appeared typical.Functional inspection was performed per ifu l07064 by attaching the handle to the returned mac blade.Lab inventory batteries were placed into the returned handle since no batteries were returned in the device.To switch on, the blade was pulled up and the blade/handle system was able to properly illuminate.Functional testing was also performed with a known good lab inventory blade.The same results followed as the blade/handle system was able to properly illuminate.Dhr for 008621000 rusch standard handle: medium, lot 210501: the device history record of lot 210501 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 that is provided for this device, (l07064), states "before use, always check: the device is free from damage.Batteries are inserted and handle cap is securely closed.Bulb and/or rusch fiberclip (fiber optic light guide) are securely attached to the blade.Operating instructions: laryngoscope handles and blades: attach blade to compatible handle.Click into place.To switch on, pull blade up.To switch off, fold blade down." corrective action is not required at this time as no problem was found with the returned sample.The handle was able to properly illuminate.The complaint cannot be confirmed.Functional testing confirmed that the handle was able to properly illuminate with multiple blades attached.No issues were identified with the light function of the handle.A device history record review was performed with no relevant findings identified.Therefore, the complaint cannot be confirmed as there was no fault found with the device.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Customer called stating that the light would not work when the blade is attached.They have changed the blubs and batteries, no change.

• Brand Name: RUSCH STANDARD 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16409570
• Report Number: 8030121-2023-00002
• Device Sequence Number: 5742540
• Product Code: CCW
• UDI-Device Identifier: 14026704711663
• UDI-Public: 14026704711663
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: IPN915486
• Device Catalogue Number: 008621000
• Device Lot Number: 210501
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown