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

Model Number IPN048573

Device Problem Continuous Firing (1123)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "the light was flickering during intubation".

Manufacturer Narrative

Qn#(b)(4).Additional information received from the sales rep indicates the issue was detected prior to use on the patient.The device was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports: the customer returned one 133300 green led handle: medium handle for investigation.The visual examination did not reveal any obvious defects or anomalies, as the device appears typical.All edges of the returned handle were examined, and it has been noted that the interlocking mechanism where the blade will be sitting in that groove area was worn-out badly, and they are indicative of abnormal wear, and the device has been used multiple times.Visual examination revealed that the worn-out groove could contribute to the flickering issues.The functional inspection was performed per laryngoscope ifu by pushing downward on the blade to release it from the handle.The blade and handle were reattached and disassembled multiple times with no issues observed of flickering.The complaint cannot be confirmed.To simulate the customer-reported failure of light flickering, we did the functional testing of the blade with two fresh blades and noted that the handle was working perfectly.There were deep scratch marks and noted on the internal locking mechanism of the handle.These marks/scratches reveals that the device has been used multiple times by the end user, and they are indicative that the groove of the handle is worn out due to increased wear and ifu states "do not re-use damaged or worn devices".During functional testing of complaint device, the customer reported defect of flickering of the handle has not been noted as we could not be able to reproduce the same defect after testing with three different blades.But using the damaged and worn devices, there might be possibilities that this could lead to flickering issue.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, "under normal conditions device function and the integrity of materials are not affected by continuous reprocessing", "always inspect the devices for damage or signs of increased wear"."do not re-use damaged or worn devices"."after re-processing, reassemble the devices"." always perform pre-use checks".The complaint cannot be confirmed.Functional inspection testing revealed that the device is working perfectly when a handle was tested with two fresh blades.It has been noted that the groove of the handle was worn out due to increased wear, and there might be a possibility that this could lead to a flickering issue.No problem was found with the returned device.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

It was reported that: "the light was flickering during intubation".

• Brand Name: RUSCH GREENLED 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15192813
• MDR Text Key: 303817484
• Report Number: 8030121-2022-00027
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704625656
• UDI-Public: 14026704625656
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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: 191001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1