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 03/31/2023

Event Type  malfunction  

Event Description

It was reported that during testing the blade cannot be removed from the handle anymore, it is stuck.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The actual device was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the customer returned one 133300 rusch greenled handle: medium for investigation.The handle was returned with a heine mac 3 f.O blade attached to it.Visual examination did not reveal any obvious defects or anomalies, as the handle 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 one of the steel ball of the blade (heine mac 3 f.O blade) was damaged and there was deep dent on the steel ball, and it was also noted that there was no spring back action force in the steel balls.The functional inspection was performed per laryngoscope ifu by pushing downward on the fresh blade to release it from the handle, part of the instructions for use (ifu) were reviewed for this investigation.The handle device was functional tested with fresh blade by following the product guidelines.No problem found on customer returned handle device.The device history record for lot 23012701 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification." the complaint cannot be confirmed.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.The device was found to be fully functional with different size blades.Other remarks: n/a; corrected data: n/a.

Event Description

It was reported that during testing the blade cannot be removed from the handle anymore, it is stuck.No patient involvement.

• 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
• MDR Report Key: 16656000
• MDR Text Key: 312450509
• Report Number: 8030121-2023-00012
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711694
• UDI-Public: 14026704711694
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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: 23012701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.