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

Model Number IPN915489

Device Problem Mechanical Jam (2983)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that the blade could not be removed from the handle, it stuck.The doctor wanted to change the blade to a smaller one, as the reported one would be too big for the patient, and so he found the defect that the blade could not be removed from the handle at all.A new handle and blade were used.

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the blade could not be removed from the handle, it stuck.The doctor wanted to change the blade to a smaller one, as the reported one would be too big for the patient, and so he found the defect that the blade could not be removed from the handle at all.A new handle and blade were used.

Manufacturer Narrative

(b)(4).The customer returned one 133300 rusch greenled handle: medium for investigation.The handle was returned with a max lite mac 4 blade attached to it.The sample is also associated with (b)(4).Visual examination did not reveal any obvious defects or anomalies, as the device appears typical.The handle and blade were badly stuck, as reported in the complaint notification.We tried to dismantle the blade with ordinary effort, but that could not be helped in any way.We applied extra force with the help of a plastic hammer to dismantle the blade from the handle and with this effort, we were finally able to remove the blade from the handle.All edges of the returned blade and handle were examined, and it was noted that the steel balls of the blade, max lite mac 4, were damaged.There were dents on the steel balls, and it was also noted that there was no spring back action force in the steel balls.A dimensional inspection was not required due to the nature of the complaint.The functional inspection was performed per laryngoscope ifu l07086 rev.01 by pushing downward on the blade to release it from the handle, part of the instructions for use (ifu) was reviewed for this investigation.The handle device was functional tested with fresh blades by following the product l07086 rev.01 guidelines.No problem found on customer returned handle device.The device history record for lot code 21092301 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The root cause indicated no problem found on the sample.Based on the investigation performed on the returned complaint handle and blade device, it was deemed that the handle was found fully functional with a fresh blade and no problem was found on the handle device and no corrective or preventive actions are needed.The complaint cannot be confirmed.Visual inspection did not reveal any obvious defects or anomalies, as the handle device appears typical.All edges of the returned blade and handle were examined, and it was noted that the steel balls of the blade max lite mac 4 were damaged.There were dents on the steel balls, and it was also noted that there was no spring back action force in the steel balls.The device was manufactured according to release specifications and tested 100% for functional testing prior to shipment to the customer.No problem was found with the returned handle device.Teleflex will continue to monitor and trend complaints of this nature.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16039622
• MDR Text Key: 308410753
• Report Number: 8030121-2022-00033
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915489
• Device Catalogue Number: 133300
• Device Lot Number: 21092301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NONE REPORTED; NONE REPORTED