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

Model Number IPN915486

Device Problem Environmental Compatibility Problem (2929)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Customer called stating that the light would not work when the blade is attached.They have changed the blubs and batteries, no change.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 008621000 rusch standard handle: medium for investigation (lot 210601).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.The customer reported lot 210501, however the device received was lot 210601.The dhrs for both lots were reviewed as part of this investigation.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.Other remarks: n/a.Corrected data: n/a.

Event 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
• Type of Device: 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: 16409582
• MDR Text Key: 309883712
• Report Number: 8030121-2023-00003
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711663
• UDI-Public: 14026704711663
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1